Quality Control Supervisor – Finished Products

MAC Incorporated

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Quality Control Supervisor – Finished Products Lake Forest, California
Job Ref:
35733

POSITION SUMMARY STATEMENT:

The Finished Product Supervisor, Quality Control, is responsible for monitoring and guiding day to day testing activities in QC laboratory. The Supervisor is required to follow cGMP regulatory requirements of 21CFR part 111, 114, and 117. The Supervisor works with and trains analysts and technicians to conduct testing on final products, reviews test results for accuracy and assures the procedure was conducted in adherence to Company SOPs and guidelines. The QC Finished Product Supervisor will also communicate to other departments outside of the QC lab to report test results for release, screening, and stability. This position will maintain the bench work compliance with cGMP & ISO 17025 requirements including Company protocols, policies and procedures.

 

DETAILED RESPONSIBILITIES/DUTIES: 

•Supervise laboratory compliance adherence to regulations, policies, SOPs and test procedures

•Supervise finished product tests for timely product release.

•Provide reports and updates to management pertaining to laboratory activities.

•Supervise OOS investigation’s and seek opportunities for system enhancements.

•Implement regulatory required test for global product compliance.

•Facilitate internal and external auditing and regulatory inspections.

•Coach, mentor, and grow analysts on their technical and career growth for the team.

•Provide troubleshooting guidance and potential solutions for laboratory testing problems.

•Maintain the instrument qualifications and monitor the maintenance, calibration, and qualification activities.

 

SUPERVISORY RESPONSIBILITIES:

•Supervise and monitor lab finished product testing for cGMP regulations compliance.

•Maintain the lab test adherence to ISO17025 accreditation status

•Encourage, motivate, and grow lab staff on their skillset.

•Provide continued improvements for testing efficiencies with innovative methods and technologies

 

REQUIRED QUALIFICATIONS:

Skills:

•Good people skill set fostering a healthy working environment and fair work distribution among chemists.

•Ability to work in a fast-paced environment while providing guidance and oversight to the QC bench testing

•Technical knowledge and experience in chemical analysis using spectroscopy (FTIR, UV-vis, NMR) and chromatography (HPLC, GC, Size exclusion, TLC, and TFF).

•Technical knowledge and experience in chemical analysis using spectroscopy (FTIR, UV-vis) and chromatography (HPLC and GC).

•Knowledge and experience with allergen tests, gluten test, and wet chemistry tests

•Knowledge and experience in Food safety on quality control

•Method Development, validation, and transfer experience

•Good presentation skillset using software such as Microsoft Office (Word, EXCEL, and PowerPoint)

•Demonstrates problem solving skills and ability to carry out responsibilities

•Strong customer and results orientation

•Good communication and interacts effectively at all levels with sensitivity to cultural diversity

•Adaptive, able to evolve with the external environmental and organizational changes

•Displays an advanced level of knowledge in the field

 

Experience:

•Laboratory Supervisory experience

•5+ years of quality systems experience for cGMP compliance

•Laboratory Compliance auditing experience

 

Education:

•Bachelor of Science in Chemistry or closely related field

•GMP Course Training

•Regulatory compliance training

 

PREFERRED QUALIFICATIONS:

•Communication and presentation skills

•Motivational skills

•Pharmaceutical or Nutraceutical GMP experience

•Materials testing experience

•Laboratory testing experience

•Microsoft Office Proficiency Course

•Methods Development, trouble shooting, training

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