QA Operations Supervisor

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Apex Systems
Full Time

Job Description

Job#: 1276853

Job Description:

QA Operations Supervisor

Apex Systems is seeking a QA Operations Supervisor near Webster, TX for a contract project with a global leader in pharma, biotech and consumer health . The QA Operations Supervisor is a member of the QA Operations team reporting directly to the QA Operations Manager and is responsible for providing supervision for day-to-day, real-time QA support/oversight of GMP Manufacturing and Quality Control Testing of cell therapy finished drug products to be used for human consumption Additionally, the QA Operations Supervisor is responsible for independently maintaining quality oversight of operational areas in prevention, identification, and resolution of events, both individually and through subordinate roles, while following Good Manufacturing Practices (GMP). They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Catalent Standard Operating Procedures. This role has direct reports which will include providing training, coaching, and delegating job assignments as needed.

*If interested in the position, please send your resume to adultmeier@apexsystems.com

RESPONSIBILITIES
  • Ensures compliance with all regulatory agency requirements and company specific regulations related to quality of product.
  • Reviews records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements.
  • Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
  • Leads Quality functions in classified areas, including checklists, aseptic intervention oversight, line clearances, and product changeover and addresses or escalates findings to proper management.
  • Author, review and approve documents such as SOPs and Material Specifications as they relate to Quality Operations. Also provides timely review and approval of another department's SOPs to support that department's procedural needs.
  • Works in collaboration with management team to prepare for the internal and external auditors.
  • Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.
  • Lead Root Cause assessment and suggests corrective action to prevent recurrence.
  • Evaluates technology transfers associated with new products or processes.
  • Execute objectives, identifying continuous improvement initiatives to gain efficiency and increase right the first time (RFT) score and monitor the progress of contractual quality deliverables.
  • Collaborates with Manufacturing and Program Management to ensure quality objectives are attained as related to client projects and internal projects.

REQUIREMENTS
  • Bachelor's Degree with emphasis on science / life sciences
  • 5+ years relevant experience, preferably working within an FDA regulated manufacturing facility
  • Experience within the biological, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance, Quality Control, Environmental Monitoring, or Validation function with a strong familiarity with general GMP documentation and Equipment/Instrumentation.
  • Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine, quality tasks.
  • Exposure to 5S and lean sigma is desirable.
  • ASQ CQE (American Society of Quality Certified Quality Engineer) is highly desirable
  • Familiarity with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210/21

#LI-GP2

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1276853
Originally Posted : 2 months ago

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