Quality Control Supervisor

4 months ago

Charles City, United States Cambrex High Point Full time

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

+ engage in work that matters to our customers and the patients they serve

+ learn new skills and enjoy new experiences in an engaging and safe environment

+ strengthen connections with coworkers and the community

Were committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today

Job Overview

Reporting to the Manager, PSG, the PSG Supervisor will provide supervisory oversight, laboratory testing support, and technical leadership for laboratory staff. The PSG Supervisor will be responsible for directing the laboratory workflow for daily testing of raw materials, supplier qualifications, in-process testing, and stability and providing on-going support for these activities.

Responsibilities

+ Coordinate daily prioritization of PSG testing, including staff and equipment utilization.

+ Maintain laboratory instrumentation, including equipment qualification, and preventative maintenance programs. May need to assist with troubleshooting and minor repairs.

+ Support training and troubleshooting efforts for staff.

+ As necessary, review completed laboratory testing to support the timely release of data, reports, and material.

+ Coordinate and oversee the status of offsite sample testing.

+ Maintain and manage cGMP and general lab systems at defined levels of compliance.

+ Draft and review various documents in support of laboratory efforts and production campaigns.

+ Maintain laboratory systems and documentation.

+ On a rotating coverage, provide laboratory on-call support coverage for all aspects of laboratory operation, including environmental testing, raw material testing, in-process testing, isolated intermediate testing, and finished good product release.

+ Work cross-functionally with other departments (such as Operations/Production) to ensure deliverables are met according to projected timelines.

+ Verify timecards and SAP billing is completed accurately and on time as per the site-specific timelines.

+ Perform the QC release for raw materials, isolated intermediates, and finished goods.

+ Identify discrepancies, author out of specification and deviation investigations within TrackWise, and implement associated CAPAs.

Qualifications/Skills

+ Familiarity with compliance requirements within cGMP, safety and regulatory environments

+ Operational knowledge of analytical instrumentation like HPLC/UPLC, GC, IC. ICP, FTIR, UV-VIS equipment, and data stations required

+ Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment

+ Strong chemistry knowledge

Education, Experience & Licensing Requirements

+ Bachelor's Degree in Chemistry, Pharmacy or closely related field required. Advanced degree highly beneficial.

+ 5 or more years of experience in manufacturing support laboratory in the pharmaceutical industry, preferably API and/or intermediate experience.

+ Hands on experience with pharmaceutical laboratory management required. Management of 24/7 lab operation highly beneficial.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

#LI-RD1

- Ability to lift and move items up to 25 pounds.

- Must be able to perform tasks requiring physical mobility, including standing for long periods, bending, and reaching.

- Exposure to chemicals, moving parts, vibration, and noise within a laboratory setting.

- May require occasional travel for training or method transfer activities.

- Flexible to work different shifts if necessary to meet critical deadlines.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

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