Title: QC Manager
Our client is a leading global contract development and manufacturing company that offers analytical services and services related to drug substance, drug product, and drug product lifecycle. We genuinely provide our clients with an end-to-end cooperation for the creation, manufacturing, and research & development of small molecule therapies at every phase of the lifecycle. We allow our clients to create and deliver therapeutic solutions that enhance patient quality of life around the world through cutting-edge science and manufacturing expertise. The QC Manager is responsible for the day-to-day operations of the isolated intermediates and finished goods testing subgroup of QC and will report to the Director of Process Support and Quality Control, oversees the subgroup's immediate daily operations.
- Write, revise, review, or approve SOPs, analytical methods, reports, and specifications as needed
- Serve as a department representative for internal/external clients for interdepartmental project meetings, inquiries, and facility audits.
- Coordinate daily prioritization of QC testing, including staff and equipment utilization, with QC Supervision and the QC Planner
- Review and approve methodology and technical reports for clarity and accuracy.
- Conduct your own important laboratory investigations for critical operating PRs that could affect commercial or regulatory items.
- Bachelor's Degree in Chemistry, Pharmacy or closely related field required.
- Advanced degree highly beneficial.
- 7 or more years of experience in manufacturing support laboratory in the pharmaceutical industry, preferably API and/or intermediate experience, with at least 3+ years in management or supervisory role in the pharma industry.
- Hands on experience with pharmaceutical laboratory management required. Management of 24/7 lab operation highly beneficial.
- Familiarity with compliance requirements within cGMP, safety, and regulatory environments
- Operational knowledge of analytical instrumentation like HPLC, GC, GC-MS, FTIR, UV-VIS equipment, and data stations required
- Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment