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QC Supervisor
2 months ago
The QC Supervisor – Finished Product (FP) will primarily assist Formulations, Supply Chain, Quality Assurance, and Production Departments by scheduling the analyses of pharmaceutical, dietary supplement, or food samples delivered to the QC laboratory. Support will be provided by ensuring that samples are analyzed using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendia monographs; client procedures; research procedures; and miscellaneous protocols. Sample analysis will mainly support commercial production or stability testing. The QC Supervisor - FP is expected to understand internal procedures and establish good laboratory practices. Additionally, the QC Supervisor - FP is expected to assist all Analytical Chemists and Scientists with method trouble shooting and compliance with all applicable procedures.
The QC Supervisor - FP will have a thorough understanding of USP, EP, ICH, and FDA guidelines as they relate to finished products, the required validations, and will lead laboratory investigations (i.e. quality investigations, out of specification investigations, etc.) as necessary.
The QC Supervisor – FP will serve as the supervisory lead on multiple projects, communicate regularly with clients, lead complex method validations / verifications. schedule staff on analytical testing, quote new projects, support monthly billing, and review and approve documents.
Essential Job Functions
- Mentors, trains, and supervises the Finished Product team. Additionally, QC Supervisor - FP will provide input and support to the Raw Material team as needed.
- Assists QC Management in the prioritization of workload and provides updates both internally and externally.
- Communicates with direct reports, management, co-workers, clients, contract laboratories, and vendors to coordinate all analytical finished product team activities such as quoting, testing, documentation, investigations, shipping, and billing.
- Drafts, reviews, and approves: SOPs, analytical methods, material specifications, deviations, and/or out-of-specification investigations.
- Drafts, examines, and implements protocols and summary reports related to routine stability studies, method validations, method transfers, and/or method verifications.
- Creates Finished Product CoA’s, as needed, to assist with the release of in-process and commercial finished products.
- Reviews Annual Drug Product Review (ADPR) documents submitted by QA for accuracy.
- Oversees testing involving dissolution, HPLC, GC, UV analysis, and various wet chemistry procedures.
- Assists all levels of Analytical Chemists and Scientists with tasks, questions, and troubleshooting of methods and/or instruments.
- Participates in on-site client and/or regulatory audits.
- Participates in contract lab qualification audits.
- Maintains awareness of changing regulatory and industry requirements (i.e. USP, FCC, EU, etc.).
- Generates and reviews QC metrics.
- Performs data review of laboratory notebooks, and forms as needed.
- Assists in maintaining a clean, organized QC laboratory.
- Conducts annual performance reviews and regular meetings with direct reports.
- Follows all client cGMP and safety practices, policies, and procedures.
- Employees work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each.
- Depending on the position, the employee will be aware of Halal and/or Kosher requirements.
- Other duties as assigned.
Education/Skills/Knowledge Required
- 5+ years of supervisory experience in a cGMP pharmaceutical environment or a or applicable cGMP environment. Advanced degree may be substituted for experience.
- Thorough knowledge and understanding in the use, methodology, and troubleshooting of QC analytical equipment (i.e. HPLC, GC, and/or dissolution apparatus) and method development.
- Proven demonstration of supervisory and leadership skills to successfully train, direct, and motivate QC personnel required.
- Advanced time management skills to complete assignments/projects in a timely manner with minimal supervision.
- Ability to establish and maintain effective working relationships with team members, co-workers, vendors, and/or clients.
Competitive Benefits:
- Medical, Dental, Vision, Life, AD&D, and Disability Insurance
- 401K Plan
- Tuition Reimbursement Program
- Paid-time Off - Accrue up to 17 days of PTO within the 1st year
