Quality Control Data Review Supervisor - Charles City - Cambrex High Point

Description

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

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

We're 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

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.

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.

Qualifications/Skills

• 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.

Education, Experience & Licensing Requirements

• 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.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

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.