Find & Apply For Quality Control Systems Manager Jobs in Lillington, North Carolina

Quality Control Microbiology Manager 800 Edwards Brothers Drive, Lillington, NC 27546 Full-time Apply with Indeed Job Responsibilities Ø To ensure that approved SOP exist for operations pertaining to compliance to cGMP/cGLP requirement and applicable GMP regulations. Ø To consistently drive company's ethics and data integrity policy. Ø To Understand and comply with SOPs, Environmental, Health, Safety, and Quality requirements and applicable regulations. Maintains awareness of industry best practices. Ø To Provide support for all testing, tasks, and documentation in support of Validation Studies including Process Validation, Media Fills, Method Validation, and development of analytical methods. Ø To Provide support of product development projects, investigations, monitoring of utilities systems, and the stability program. Ø To ensure that the Laboratory has required SOPs, Standards, and Specifications & Methods of analyses to perform the testing activities assigned to Microbiology laboratory. Ø To monitor calibration checks and performance checks of instrumentation and devices such as RCS, pH meters, balances and refrigerators. Ø To review Laboratory Notebooks and Logs as detailed in applicable procedures. Produces periodic reports for tracking, evaluation of trends, associated metrics, etc Ø Trains and qualifies personnel for Aseptic Operations, Microbiological Sampling and Testing, and associated documentation. Trains Microbiologists, assigns tasks, monitors their performance, and reviews their testing and documentation. Ø To develop and monitor quantitative and qualitative microbiological tests such as for media controls, enumeration, sterility testing, absence of index organisms, classification and speciation, antimicrobial effectiveness, etc. performed by all QC Microbiology personnel. Ø To develop and Monitor sampling and testing as required for monitoring of critical systems, Purified Water, Clean Steam, Clean Compressed Air, etc. Ø Monitor sampling and testing as required for environmental and personnel monitoring, samples of raw materials, in-process product, and finished product. Ø To review tracks and reports on Quality System Metrics relevant to testing, OOS Investigations, and training in support of Quality Systems Reporting to management. Ø To Provide QA Support for Audits and Inspections. Ø To develop and / or monitor the system for approval or rejection of documents. Ø To implement effective monitoring and control procedures to achieve Quality system objective. Ø To review and Approve/Reject the department documents such as change control, deviation, CAPA, laboratory and production failures investigation, OOS, OOT, LIR, market complaints, product recall etc. Ø To provide necessary support and input to R & D during product/process development, technology transfer and new product launches. Ø Works as a member of a team to achieve all outcomes. Ø Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Ø Performs all work in support of our

Values:

Collaboration, Courage, Perseverance, and Passion. Ø All other relevant duties as assigned.

Physical Demands:

Required to stand, walk, sit, talk and hear; required to use hands to operate vehicles and office equipment; must be able to occasionally lift and/or move up to 50 lbs; specific vision requirements for this job include: close, distance and peripheral vision, and the ability to adjust focus, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position without compromising patient care. KriGen Pharmaceuticals is an equal opportunity employer. All employment decisions are made without regard to age, color, race, ancestry, national origin, disability, genetic information, military status, religion, creed, sex, pregnancy, childbirth, marital status, citizenship, sexual orientation, gender identity, gender expression, legally protected medical condition, or any other basis prohibited by applicable law. Background checks and drug screens are part of our hiring process. Affirmative Action/Equal Opportunity Employer, Minority/Female/Disabled/Veteran.

Benefits:

Dental insurance Health insurance Paid time off Vision insurance Application Question(s): What is your salary Expectations? Master of Microbiological science / Pharmaceutical Science or Relevant field

Experience:

Pharmaceuticals manufacturing

Microbiology Laboratory:

10 years (Preferred)

Work Location:

In person