Quality Control Manager, Process Support Group
- Military veterans preferred
2025-09-20 Cambrex
Other
/yr
employee
contract
Charles City Iowa 50616 United States
Cambrex
Quality Control Manager, Process Support Group
US-IA-Charles City
Job ID: 2025-4488 Type: Regular Full-Time Category: Quality Control Cambrex - Charles City
Overview
Reporting to Director of Process Support and Quality Control, the Manager, PSG is responsible for the immediate day to day operations of the in-process and raw material testing subgroup of QC. In the absence of the Director, the Manager of PSG may be responsible for supporting the operation of the PSG and QC team. The Manager of PSG will provide technical support and leadership for the laboratory staff, allocate laboratory resources to meet production timelines, and work to improve overall testing efficiency. Interaction with all areas of the manufacturing plant site will be inherent in this position.
Responsibilities
Serve as a department representative for internal/external clients for interdepartmental project meetings, inquiries, and facility audits.
Write, revise, review, or approve SOPs, analytical methods, reports, and specifications as needed.
Coordinate daily prioritization of in-process and raw material testing, including staff and equipment utilization, with QC Supervision and the QC Planner
Maintain and manage cGMP and general lab systems at defined levels of compliance.
Oversee the assignment of QC resources and monitor the daily progress relative to communicated production needs.
Utilize and develop metrics to decrease sample throughput time in PSG.
Review and approve methodology and technical reports for clarity and accuracy.
Draft and review various documents in support of laboratory efforts and production campaigns.
Own critical laboratory investigations for critical process PRs that may impact regulatory or commercial items.
Oversee and track weekly production and shipping needs.
Working with the Director, monitor immediate project scopes for the current fiscal quarter to ensure the active or scheduled campaigns have the required materials required for laboratory support.
Verify monthly deliverables (including SAP billing) are completed on time and are accurate.
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Qualifications
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/UPLC, GC, IC. ICP, FTIR, UV-VIS equipment, and data stations required
Equal employment opportunity, including veterans and individuals with disabilities.
