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30 days old

Quality Manager

Kelly Services
Arlington, TX 76015
**Quality Manager** (Food & Pharmaceutical)


Kelly Science & Clinical is currently recruiting for a direct hire Quality Manager in food/pharmaceutical with global manufacturing organization located South of Arlington, TX.


**Job Responsibilities:**


Manages the overall Quality function for the facility. Responsible for maintenance of all regulatory licenses and documentation; including Drug Master File (DMF), Certificate of Suitability (CEP) and on-site Standard Operating Procedures (SOPs) and the GFSI/SQF Food Safety and Management System.


+ Responsibilities include maintaining plant wide conformance to HACCP and Pre-requisite Programs, FDA/cGMP/ICH regulations. Coordinates, investigates, and documents all nonconformance's including customer complaints.

+ Manages all regulatory and customer audits and inquiries. In the Quality Manager's absence, the Quality Lab Supervisor and Director of Quality and Development will provide coverage.

+ Complies with company Health, Safety and Environmental policies, procedures and arrangements.

+ Reports all Health, Safety and Environmental accidents, incidents and near misses promptly.

+ Acts in a safe and responsible manner at all times

+ Responsibility and authority to oversee the development, implementation, review, maintenance, and management of the on-site Quality program for the facility including GFSI/SQF. This includes food safety fundamentals, food safety (HACCP) plan and food quality plan.

+ Must take appropriate action to maintain the integrity of the Quality / SQF system and communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF system.

+ Must approve all plant procedures and any changes that may affect the Quality of the product.

+ Authority for final release of all products for distribution.Maintains all regulatory documents including licenses, DMF, CEP and site SOPs and HACCP plans.

+ Maintains the MOC Management of Change, OOS Out of Specification, Deviation and CAPA Corrective and Preventive Action programs.Works closely with the Quality Laboratory Supervisor to oversee and coordinate daily workload to ensure timely release of finished goods.

+ Manages/coordinates flow of documentation from Production depts. to Quality dept. to ensure timely review of documents.

+ Maintains SOPs and Forms on the COMPANY DMS Document Management System.

+ Manages and conducts plant-wide cGMP training to assure compliance with all regulations.

+ Trends data and reports potential problems to Management.

+ Approves the Stability Program and Annual Product Review for the facility.

+ Coordinates all on-site regulatory and customer audits and provides written responses as necessary in a timely fashion.

+ Coordinates the investigation of all customer complaints/dissatisfactions and provides written documentation as required.

+ Responsible for auditing of both contract laboratories and processors including evaluation of proposed new and alternate raw material suppliers.

+ Develops and implements new and/or improved programs to assure continual Quality improvements.

+ Manages the Quality department budget (not including salaries), through direct involvement and management of Quality laboratory personnel and QC inspector.

+ Performs other duties as assigned.


**Education & Qualifications:**


+ BS degree in Chemistry or Engineering with a MS preferred.

+ SQF Practitioner with HACCP training and PCQI (Preventive Control Qualified Individual)

+ Working knowledge of regulatory requirements for active bulk pharmaceuticals (API)

+ Minimum of five years experience in a Food and/or pharmaceutical manufacturing environment

+ Computer literate: MS Word, Excel, Access, PowerPoint; SAP experience preferred

+ Experience in a manufacturing environment preferred.

+ Ability to solve practical problems and deal with a variety of changing situations.

+ Technical/Professional Knowledge and Skills analysis

+ Strong time management and prioritization skills

+ Day Shift


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-15 Expires: 2022-08-15

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Quality Manager

Kelly Services
Arlington, TX 76015

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