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Quality Control Manager

Company: LGM Pharma
Location: Irvine
Posted on: November 25, 2022

Job Description:

LGM Pharma is a leading contract development and manufacturing organization (CDMO) and provider of Active Pharmaceutical Ingredients (API). With excellent API sourcing and supply chain expertise together with our drug product contract development and manufacturing solutions, we are a premier end-to-end solutions provider to the global pharmaceutical industry.

We are a high-growth organization looking to accelerate the development and commercialization of high-quality therapeutics worldwide. We have offices in California, Texas, Kentucky, Florida and Israel.

We are looking for a QC Manager to join our Quality Control Department, in Irvine, CA.

*PRIMARY DUTIES AND RESPONSIBILITIES: *

- Maintain and supervise the daily activities of the QC laboratory by establishing testing priorities and scheduling of staff in coordination with company goals/priorities.

- Provide daily guidance, mentoring, and feedback to staff.

- Overseeing product testing to identify any deviations/out of specifications. Perform and assist with laboratory investigations and other quality events as necessary.

- Schedule use of equipment/instrument with other analytical groups.

- Ensure QC equipment calibrations and maintenance are completed in a timely fashion.

- Review laboratory notebooks, raw data, reports, protocols, etc., as necessary.

- Author/review QC analytical SOPs, protocols, etc. Perform change controls to update current analytical GMP documents.

- Ensure QC laboratory compliance with applicable regulations.

- Author/review method validation protocols/reports. Oversee/perform method development/validation/ verification activities for API and drug products.

- Supervise procedural, cGMP, and safety training of laboratory staff.

- Attend meetings, generate/submit reports to upper management, perform and maintain departmental metrics.

- In coordination with QA, ensure QC activities adhere to cGMP regulations and any other regulatory guidelines.

- Assist with preparations for internal and external laboratory audits and inspections.

- Other related duties as required.

*QUALIFICATIONS: *

- Bachelors or higher degree in Chemistry or related discipline.

- 5+ years experience (2+ years in a supervisory role) in a QC or analytical chemistry laboratory

- 3+ years experience in GLP or GMP (preferred) environment.

- Understanding of FDA regulations (21 CFR 210, 211, 110, 111, 11, etc.) and USP, EP and FCC.

- Skilled in understanding scientific and technical data*. *In depth knowledge of analytical testing of raw materials, in-process samples, finished products and analytical laboratory instrumentation, such as HPLC, GC, CE, ICP, FTIR, TOC, dissolution apparatus, etc.

- Demonstrated ability to manage timelines and act in a lead capacity and provide direction to others.

- Possesses strong investigational skills to determine root cause and identify effective corrective actions.

- Strong communication and listening skills, with strong observational, analytical, and problem-solving skills. Knowledgeable with regulatory compliance and be skilled in understanding scientific and technical data.

- Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.

Job Type: Full-time

Pay: From $90,000.00 per year

Benefits:
* 401(k)
* Dental insurance
* Employee assistance program
* Flexible spending account
* Health insurance
* Life insurance
* Paid time off
* Referral program
* Vision insurance
Schedule:
* 8 hour shift
Supplemental pay types:
* Signing bonus

COVID-19 considerations:
Practicing Social Distancing, wearing assigned face coverings, routine cleaning

Education:
* Bachelor's (Required)

Experience:
* QC Laboratory Environment: 5 years (Required)
* GLP or GMP (preferred) environment.: 3 years (Required)
* management: 2 years (Required)

Shift availability:
* Day Shift (Preferred)

Work Location: One location%58047475%

Keywords: LGM Pharma, Irvine , Quality Control Manager, Executive , Irvine, California

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