This position will include the following major areas of responsibility.
Responsibilities:
DUTIES & RESPONSIBILITIES:

Train laboratory technicians in the proper means of raw materials, in-process and finished product testing
Follow up to ensure accuracy and reliability of technicians’ work including their input of data into the computer system
Conduct analysis on all products and ingredients to determine conformance to microbiological standards and advise of potential liability conditions
Analyze and record all quality attributes for produced and purchased products within the parameters of plant production and/or customer requirements
Perform necessary calculations required for standardizing products or for adjustment of oil, solids, pulp, and other quality parameters of all blended products
Clean, calibrate and maintain test equipment
Evaluate performance of lab technicians and provide positive and constructive feedback daily
Function as a technical resource in documenting yields for all produced products
Responsible for the accuracy and documentation of the daily Quality Control production records for all produced products
If required, collect samples, analyze results and document plant waste effluents and prepare written reports for the City of Ventura Sanitation Department on a weekly or as needed basis
Interact with sales, customer service, and production departments in order to achieve the goal of servicing the customers’ needs
Perform daily sanitation, GMP, and other required inspections.
Examine production paperwork to verify that the HACCP parameters have been met
Promote safety in the department and ensure that all technicians adhere to all safety regulations
Ensure that all technicians are following all food safety and personal hygiene practices
Demonstrate reliable attendance, consistent punctuality and a positive attitude at all times
Ability to use laboratory equipment such as refractometer, buret, automated analytical instrument
Ability to communicate effectively both in verbal and written formats
Responsible and can manage others timely and effectively
Perform other duties as required and assigned

REQUIRED QUALIFICATIONS & BACKGROUND:

Minimum Qualifications


Bachelors Degree in scientific or food related discipline
At least 2 years of leadership experience
Supervisory experience
Has worked with a computer system for input and extraction of data
Worked with governmental agencies
HACCP certified

Email: Lewie Casey
Talent Manager, Med Exec International & Research Staffing

Phone: 818-552-4173

This position will include the following major areas of responsibility.
Responsibilities:
DUTIES & RESPONSIBILITIES:

The Operations Director will embrace efficiency and position our company for rapid, sustained and profitable growth.
He/She will take ownership over an entire facility with management responsibilities that will include manufacturing and inventory control along with profit & loss performance.
The operations Director will lead by example and demand an environment of respect for others with the clear understanding that he/she is ultimately responsible for the work product and results of an entire Division and stand-alone Facility.

REQUIRED QUALIFICATIONS & BACKGROUND:

Minimum Qualifications


Strong leadership skills demonstrated through championing accountability, maximizing team and individual strengths, seeking and implementing change, and aligning with critical plant and business objectives.
5+ years experience in senior operational and strategic leadership.
Extensive, hands-on, in-depth knowledge of lean and continuous improvement methodologies.
Proven ability to drive communication throughout an organization that both anticipates and removes roadblocks.
Capable of leading and implementing the practical application of the full range of lean methods on the plant floor.
Should have implemented lean practices in at least two separate operating environments.
Solid skills in motivation and employee development; proven ability to educate and train others in new ways of doing business.
Former military background is a plus
Hands on attitude, with the willingness to be on the production floor
Talent for recognizing better and innovative ways to accomplish objectives.
Ability to effectively manage multiple projects/initiatives with budget limits and time constraints.
Effectively designed strategic plans that have led to growth of a manufacturing company
Demonstrated on-time and quality standards
Experience with international suppliers and customers
Demonstrated commitment to change management
Demonstrated leadership in process improvement
Technical aptitude in understanding complex manufacturing issues and processes.
Lean manufacturing (related) certification preferred

Applicants for employment in the U.S. must possess work authorization, which does not require sponsorship for a visa now or in the future.

American Work Force



Email: 52602@americanworkforce.jobs

This position will include the following major areas of responsibility.
Responsibilities:
DUTIES & RESPONSIBILITIES:

Develop, implement, and improve overall quality systems and reliability of products.
Qualify equipment required to perform inspection - design and/or procurement.
Validation, testing, inspection, and sampling.
Transfer of design to contract manufacturer.
Qualification and validation requirements.
Interface directly with suppliers.
Support Non-Conforming Material Program.
Help analyze CAPA Program and resolve product quality issues.
Identify and trend quality issues.
Train employees and document.

REQUIRED QUALIFICATIONS & BACKGROUND:

Minimum Qualifications

A BS/BA in an engineering or technical discipline.
5 years experience in a regulated environment required.
Supplier Management experience required.
Strong Design Control experience required.
Packaging or validations experience required.
QSR, ISO 13485, and the MDD experience required.
ASQ Certified Engineer (CQE) preferred.

Principals only need apply. NO agencies need respond.

Lewie Casey

Med Exec International

Email: lcasey@medexecintl.com

Phone: 818-552-4173

This position will include the following major areas of responsibility.
Responsibilities:
DUTIES & RESPONSIBILITIES:
Lead QA/RA efforts by actively participating as member of cross-functional team (as assigned) and ensuring quality and regulatory compliance and best practices in areas of design, manufacturing and complaint handling activities.

Lead/Support key QA/RA activities, as assigned. May include, but are not limited to activities in the following areas:

a) Design and Development activities.
b) Production and Process Controls.
c) QA investigation and root cause analysis of customer returns / complaints.
d) NCMR/CAPA, complaints, FMEA, and risk management
e) Supplier Quality Management, including Supplier Qualification, Supplier Rating Systems, and development of inspection plans.

Write validation (IQ, OQ, PQ) protocols, perform or manage performance of protocols, analyze data and write validation reports
Support company goals and objectives, policies and procedures, quality systems, and FDA regulations.

REQUIRED QUALIFICATIONS & BACKGROUND:

Minimum Qualifications

Technical degree—BS in quality engineering or equivalent
Minimum 3 to 5 years experience working in regulated medical device environment and quality control / assurance or regulatory assurance.
Software experience: Minitab Statistical Software, MS Office
Experience in statistics, including DOE and gauge repeatability and reproducibility.
Demonstrated effective interpersonal and networking skills.
Demonstrated ability to successfully comprehend and carry out / execute actions.
Sigma Green Belt certification, or acquiring certification within first year is highly desirable.

Principals only need apply. NO agencies need respond.

Bausch & Lomb, Surgical



Apply here for the Position number 5475BR

This position will include the following major areas of responsibility.
Responsibilities:
Train shop employees in production processes, current Good Manufacturing Processes (cGMP) and safe shop practices
Support design engineering by providing design inputs and manage the design review meetings
Set rules for SPC, investigate root causes of production problems and recommend improvements to prevent reoccurrence
Generate design and process FMEA’s, risk analyses and perform process validation studies (IQ/OQ/PQ)

REQUIRED QUALIFICATIONS & BACKGROUND:

Education: Bachelors Degree in Mechanical Engineering or related engineering discipline and / or 4 + years experience in a related field and plastics manufacturing
Experience, Knowledge and Skills:

Hands on utilization of Statistical Process Control (SPC) and Measurement System Analysis (MSA)
Design and process FMEA experience
Internal and supplier auditing to ISO13485 and or FDA QSR
Strong analytical and report writing skills
Strong communication and interpersonal skills
Competence in Microsoft Office tools
One to four years experience in validation or quality engineering in disposable medical device manufacturing environment
Experience in a regulated environment a plus

Principals only need apply. NO agencies need respond.

Kaitlyn Nash
Medi/Nuclear Corp
4610 Little John St.
Baldwin Park, CA 91706
Fax 626-960-9822


mcarrasco@medinuclear.com

This position will include the following major areas of responsibility.
Responsibilities:
DUTIES & RESPONSIBILITIES:
Partner with plant managers and other key executives to effectively deploy quality assurance and quality control policies and drive best practices across the organization.

Provide support to manufacturing facilities in California, Connecticut, and Mexico.

Work with Research and Development, Engineering, and Production to develop schedules, project plans, and cost estimates for implementing new activities, procedures, or methods to improve the quality and performance of the organization’s products.

Research, evaluate, and recommend investments in technology, capital, equipment, systems, or other assets that will improve the quality of the organization’s raw materials, in-process products, and finished products.

Work with external suppliers to ensure that their products meet the organization’s quality standards and that the organization receives satisfactory standards of service.

REQUIRED QUALIFICATIONS & BACKGROUND:

Education: Bachelors degree in Business, Engineering or related field. MBA a plus.

Experience: 10 plus years of experience in Quality, Manufacturing or related work experience, with guitar and/or pro audio electronics manufacturing a plus.
Strong musical instrument, amplification and pro audio technical background with a complete understanding of raw material and component specifications a plus.
Knowledge of and experience with ISO-9000 standards and formal quality systems.

Formal Six Sigma Certification, ACE, and/or SPC training desirable.
Knowledge of Lean Manufacturing principles a plus.

Ability to make independent, impartial, and appropriate recommendations and decisions.
Ability to lead and influence at all levels of the organization.
Bi-lingual (English & Spanish) a plus.
Significant travel required (50%+) to various plant locations.

Principals only need apply. NO agencies need respond.

Cindy Hanifen – Senior Executive Recruiter – Industrial Practice
Korn/Ferry International, Futurestep Inc.
14295 Midway Rd. Suite 450
Addison, TX 75001
Direct dial: 972-383-1605

Cindy.hanifen@futurestep.com

This position will include the following major areas of responsibility.
Responsibilities:
DUTIES & RESPONSIBILITIES:

Design verification, validation, and qualification of all hardware and software through strategic supplier development, inspection methods and processes, LEO manufacturing and test processes development, and metrics.
Generate non-conformance reports and participate in the Material Review Board meetings. Develops innovative and practical solutions to advanced and unique technical problems utilizing advanced quality techniques. Utilizes FRACAS database to track production and fielded problems and creates metrics for trending of failures and determination of root cause and corrective action.
Utilize and conducts training on the use of quality tools (i.e. FMEA, FRACAS, Cp/Cpk, DOE, Ishikawa etc.).
Facilitates and participates in program and product cost reduction initiatives.
Provides competent and timely recommendations to management, anticipating future needs and required development.
Program point of contact for technical communication on quality issues.
Assists in resolving complex technical problems by providing guidance and facilitation in determining root cause. Develops and implements methods and procedures for inspecting, testing and evaluating products for acceptability.
Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company.
Expected to work in a safe manner in accordance with company established procedures and practices.
Other duties as assigned or required.

REQUIRED QUALIFICATIONS & BACKGROUND:

Minimum Qualifications

A Bachelor's degree in quality, engineering or related mechanical/optical technical field with at least 9 years of related experience, or 7 years related experience with a Master's degree.

Certified Quality Engineer (ASQE).
Six Sigma training/experience.
Able to read and understand mechanical, optical and electrical drawings using ASME Y14.5 standards.
Knowledge of manufacturing processes, optical and laser systems component inspection and handling and nondestructive examination techniques.
Knowledge of ISO 9001:2000 standard and CMMI Dev 1.2.
Excellent communication and interpersonal skills for interfacing with all levels of employees and customers and a strong “team player” attitude.
Must be able to obtain security clearance for this position.

Desirable Qualifications

Detail oriented to accurately prepare statistical reports, specifications, procedures, and technical documentation.
Knowledge of computer operations and applications.
Quality systems audit experience.
Experience with Relex database and certified reliability engineer a plus.

Principals only need apply. NO agencies need respond.

Apply here

This position will include the following major areas of responsibility.
Responsibilities:
Positions require knowledge of AS 9100 Aerospace experience.
Knowledge of Electronics, electro-mechanical and fabricated machine parts are a plus.
Must be a dynamic leader.

REQUIRED QUALIFICATIONS & BACKGROUND:

Must be a US Citizen.
Must have the Management Experience.
Manage 5-8 direct personnel .
Six-Sigma Experience.
Must be Pro-Active .
Strong Leader, a coach, mentor, decision maker!
Ability to work well with all levels of management .
Prefer: local California candidates

Principals only need apply. NO agencies need respond.

SweigartBJ@aol.com

SweigartBJ@aol.com Tel #: (619) 876-6150

This position will include the following major areas of responsibility.
Responsibilities:
Coordinate, schedule and participate and/or perform internal cGMP and GLP compliance audits of the manufacturing, quality control testing, and warehouse facilities and operations.
Coordinate, schedule and participate and /or perform cGMP and GLP compliance audits of company’s suppliers and contract laboratories. This may require approximately 10% domestic and international travel.
Coordinate, schedule and participate in audit activities associated with company’s customers.
Participate and assist in the activities associated with regulatory inspections.
Play an active role in the development, coordination and presentation of training programs within the areas of responsibility for the department and for others.
Writes and revises documents and procedures relevant to the auditing function.
Issues audit reports, assist as required in the audit responses, verify the implementation and evaluate the appropriateness of corrective actions.
Assist in other departmental activities as determined by the department manager.

REQUIRED QUALIFICATIONS & BACKGROUND:

At least four years of experience in Regulatory Compliance, Regulatory affairs, Quality Engineering, Quality Control or Quality Assurance conducting cGMP and GLP audits of Manufacturing, Laboratory and Warehouse operations internal to companies and/or suppliers.
Experience in the Pharmaceutical, Biologics, Medical Device or other Health Care industry is also required.
A minimum of a Bachelor Degree in one of the Life Sciences, Health Care or other Science or Engineering Bachelor Degree.
Certification in industry auditor training programs, such as (ASQ, RAPS, ISO etc.) is mandatory.
Working knowledge and understanding of concepts of cGMP and GLP.
Understanding of industry standard operational/manufacturing practices.
Knowledge of US and international regulations and practices pertaining to the manufacture and testing of pharmaceutical and biologics products.
Good verbal, written communication and negotiations skills.
Computer literacy with proficiency in MS Word, Access, and knowledge of Excel and PowerPoint.
Able to work independently with minimal supervision.
Well developed communication skills especially in stand-up presentation or facilitation.
Willing to travel as needed, domestically and internationally, with overnight stays from one to two days to up to two weeks.
Good leadership and interpersonal skills, with the ability to direct the work of others.
Able to adhere to Manufacturing and QC Laboratory gowning and safety procedural requirements. This position requires frequent gowning in-order to support audit activities in the environmentally controlled facilities during internal audits, customer audits, regulatory audits and supplier audits.

Principals only need apply. NO agencies need respond.

Kerry Clark
Grifols Biologicals

Kerry.Clark@grifols.com

Please apply with a subject line of Auditor.

This position will include the following major areas of responsibility.
Responsibilities:
Support and manage the routine EM Program on a daily basis.
As necessary follow procedures to collect and process environmental monitoring samples such as viable, non-viable, surface, personnel, water and gases as scheduled.
Coordinate daily environmental monitoring schedule and assign staff with daily tasks.
Must be willing and able to support changing manufacturing schedule to coordinate necessary monitoring with the EM group.
Provide technical and administrative support for investigations and corrective actions relating to EM excursions. Ensure closure of issues and investigations promptly.
Responsible to issue, update and maintain the database and log books routinely.
Prepare and review weekly, monthly, quarterly and annual product quality trend reports for management review and regulatory submissions.
Coordinate, manage and report EM investigations relating to excursions, trend analysis or issues. This will require extensive analysis utilizing multiple resources from various departments.
Prepare and review procedures, study protocols and validation protocols and reports relating to facility EM projects.
Gathers and studies data to understand trends and issues and to make recommendations related to product safety and quality in areas of assigned responsibility
Assist to perform audits in manufacturing areas, report issues to area management and facilitate closure of audit observations.
Issue and/or investigate observation reports, environmental observation reports, and corrective actions as needed.
Must demonstrate professionalism when interacting with personnel and management from within the department as well as other departments in the company.
Closely interact with and support manufacturing and quality personnel in all aspects of EM observations, process improvements and investigations.
Will interface with FDA or other inspection authorities during cGMP inspections.

REQUIRED QUALIFICATIONS & BACKGROUND:

BS degree in Microbiology and Chemistry (preferable), Biochemistry, Biology, or allied Science field.
Minimum of 4-5 year’s pharmaceutical QA experience.
Experience in environmental monitoring quality systems is preferred.
Demonstrate strong problem solving skills, with leadership and project management ability.
Quick learning capability, high sense of responsibility and flexibility to adapt to a fast paced work setting. Must be able to work in an independent as well as team environment.
Strong knowledge of US FDA cGMPs regulations. Knowledge of EU regulations is a plus.
Strong interpersonal skills with excellent technical writing skills. Communicates effectively and efficiently with individuals at all levels of the organization.
Must have knowledge and experience to analyze, conduct investigations and write Root Cause Analysis (RCA) reports for management review.
Demonstrate competence in MS-Word, MS-Excel, MS-Access, MS-PowerPoint.
Strong organizational skills, including the ability to prioritize workload. Highly motivated individual to function at an autonomous level with minimal supervision.
Must have demonstrable flexible & out of the box thinking approach to problem solving and process improvement.
Must be able to gown to enter manufacturing area to perform inspections and sampling as needed.
Must be able to carry out tasks in a standing posture and able to lift up to 25 lbs if needed

Principals only need apply. NO agencies need respond.

Kerry Clark
Grifols Biologicals

Kerry.Clark@grifols.com

Please apply with a subject line of QA Supervisor.

This position will include the following major areas of responsibility.
Responsibilities:
Supervise the daily activities in the QC chemistry laboratory to ensure that all GMP, company specifications, procedures and guidelines are followed.
Plan and analyze work flow, delegate and prioritize tasks, to ensure tests are done in a timely manner.
Understand, and assist when needed, routine product (in-process and final container) testing.
Direct the identification of analytical abnormalities and offer explanations and/or solutions where possible.
Oversee the review of test record results for accuracy and completeness and oversee the maintenance of accurate and complete records.
Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
Daily management of QC Chemistry personnel.

REQUIRED QUALIFICATIONS & BACKGROUND:

BS or MS in chemistry, biochemistry or related scientific field.
Three or more years experience in a pharmaceutical or biologics laboratory or equivalent.
Prior supervisory, team or project leadership experience.
Experience with GMP-compliant computer-based data management systems (LIMS or similar) is also desirable.

Principals only need apply. NO agencies need respond.

Kerry Clark
Grifols Biologicals

Kerry.Clark@grifols.com

Please apply with a subject line of QC Chemist Supervisor.