Quality Control Data Review Supervisor

Cambrex•Charles City, IA

About The Position

The QC Supervisor, Data Review provides supervisory oversight, technical leadership, and subject-matter expertise for analytical data review activities within a cGMP Quality Control laboratory supporting API and intermediate manufacturing. This role is responsible for managing the data review workflow, ensuring timely and accurate release of raw materials, intermediates, finished goods, and stability results, and supporting the laboratory’s robust state of compliance. The Supervisor ensures that data integrity principles are consistently upheld and that QC operations meet CDMO client expectations and regulatory requirements.

Requirements

Strong working knowledge of cGMP, data integrity regulations, and laboratory compliance expectations.
Proficiency with LIMS, chromatography data systems (e.g., Empower), electronic documentation systems, and TrackWise (or similar).
Strong computer literacy including spreadsheets, word processing, structural analysis tools, and databases.
Strong leadership, communication, and mentorship abilities.
Proven ability to manage multiple priorities in a fast-paced, project-driven CDMO environment.
Detail-oriented with excellent problem-solving and decision-making skills.
Bachelor’s degree in Chemistry or closely related scientific field required; advanced degree preferred.
Minimum 5 years of experience in a pharmaceutical QC laboratory supporting manufacturing; API/intermediate and CDMO experience strongly preferred.
Prior experience supervising or leading QC analysts or data review personnel required or strongly preferred.
Demonstrated expertise reviewing and interpreting analytical data from techniques such as HPLC, GC, FTIR, UV-Vis, KF, titration, and wet chemistry.
Hands on experience with pharmaceutical laboratory management required. Management of 24/7 lab operation highly beneficial. Role includes periodic, rotating, on-call coverage.

Responsibilities

Supervise QC data review staff, including workload delegation, performance management, coaching, and development.
Coordinate daily prioritization of analytical data review activities.
Oversee data review queues to ensure timely data approval and release of materials, intermediates, and final API products.
Support resource planning, scheduling, and capacity management for QC operations.
Review and approve analytical data packages, including raw data, electronic records, chromatographic results, calculations, and COAs, ensuring accuracy, traceability, and compliance with ALCOA+ data integrity principles.
Identify data discrepancies and author or support OOS, OOT, and deviation investigations; ensure timely closure and effective CAPA implementation within TrackWise.
Maintain and manage cGMP-compliant laboratory documentation systems, including instrument logbooks, laboratory notebooks, training records, analytical records, and SOPs.
Provide hands-on training and mentorship to staff on analytical techniques, data analysis, and cGMP practices.
Ensure QC laboratory operations comply with FDA, ICH, DEA, EPA, and internal cGMP requirements.
Promote a safe laboratory environment and enforce all company safety rules, risk mitigation practices, and chemical handling procedures.
Support regulatory inspections, client audits, and internal audits; lead responses and corrective actions related to QC data review.
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.