Quality Control (QC) Supervisor

Company Description

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Job Description

The QC Supervisor is responsible for managing a Quality Control (QC) team, ensuring staff development, timely support for manufacturing, safety and GMP compliance. This role will provide technical and compliance guidance to ensure the safety and productivity of the group, as well as embrace continuous improvement in all aspects of QC operations.

Key Responsibilities / Accountabilities

• Oversees and directs the work of Quality Control Chemists who perform GMP testing of raw materials, intermediates, and APIs in support of pharmaceutical manufacturing.
• Interacts with Production teams to assess Quality Control support needs and coordinates coverage for all shifts on assigned team.
• Assigns projects/ responsibilities to the QC team
• Supervises QC personnel (including hiring decisions, evaluations of performance, and identification of training and development needs).
• Owns and participates in Deviation and OOS investigations, and pushes them toward closure
• Develops, improves, and revises SOPs, test methods, and other GMP documentation.
• Assures compliance of laboratory operations and contributes to laboratory organization
• Leads the transfer of analytical procedures from the Analytical Development group as well as directly from the client sites.
• Identifies and leads continuous improvement initiatives.
• Communicates with internal and external clients.
• Actively participates in quality and safety audits and walkthroughs.
• Directs and advises the Quality Control group to achieve long and short-term goals and objectives.
• Provides guidance and direction to other staff to implement the company Quality vision
• Always ensure the security and safe handling of all controlled substances. Strictly adhere to all Company and DEA regulations.
• Ensure that waste is appropriately characterized, labelled, stored and disposed in compliance with all Company, state and federal regulations. Work collaboratively with Environmental, Health & Safety, as appropriate.
• Other responsibilities as assigned

Qualifications

• BS in Chemistry, or equivalent, with 5 years related experience or MS in Organic Chemistry or equivalent with 3 years related experience required
• Experience with common analytical techniques such as HPLC/UPLC, GC, NMR, UV-Vis, pH meter, KF, FTIR, and Refractive index required
• 3 years’ experience using chromatography (GC, HPLC/UPLC) required
• 2 years' experience with Quality records (e.g. deviations, CAPA, OOS) required
• 3 years’ Previous GMP experience required
• Experience with the creation and revision of GMP documents (e.g. test methods and SOPs) required
• Skilled in the use of Microsoft Office (e.g. Excel, Word)
• Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents.
• Ability to work independently and in a team environment
• Good written and verbal communication skills. Experience communicating effectively to management as well as peers and junior chemists
• Good time-management skills and dependability regarding daily tasks
• Experience training other chemists on test methods and QC operations
• Ability to write clear and concise technical reports
• Ability to make data-driven decisions
• Previous experience leading other chemists in a GMP environment preferred
• Familiarity with Laboratory Information Management Systems (LIMS) preferred
• Experience with Empower chromatographic software preferred
• Experience with statistical analysis of data preferred
• Experience with 5S preferred

Additional Information

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.