Cambrex ยท 1 day ago
Quality Control Data Review Supervisor
Charles City, IA
Full-time
Onsite
Senior Level
5+ years expCambrex is a leading global contract development and manufacturing organization that provides drug substance development and manufacturing. The QC Supervisor, Data Review oversees analytical data review activities within a cGMP Quality Control laboratory, ensuring compliance and timely release of materials and products.
AnalyticsBiotechnologyInnovation ManagementManufacturingMarket ResearchPharmaceutical
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
Qualification
Required
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
Preferred
Advanced degree preferred
API/intermediate and CDMO experience strongly preferred
Prior experience supervising or leading QC analysts or data review personnel strongly preferred
Benefits
Healthcare
Life insurance
Planning for retirement
Company
Cambrex
Cambrex is a small molecule company that offers drug substance, drug product, and analytical services.
1001-5000 employees
H1B Sponsorship
Cambrex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (19)
2023 (16)
2022 (15)
2021 (7)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
unknown2019-08-07Acquired
1987-10-02IPO
Leadership Team
Tom Loewald
Chief Executive Officer
Robert Green
EVP & Chief Financial Officer
Recent News
Company data provided by crunchbase