QA Data Coordinator

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 Quality Assurance Data Coordinator will be responsible for supporting the QA department in respect to batch record preparation and labels. The QA Data coordinator will also be responsible for maintaining records and filing. This position reports to the QA Manager. 

Responsibilities

Accountabilities and Responsibilities:

• Issue requested batch records for next day’s production and attach necessary stamped labels
• Label coordination/management-design, etc.
• Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations.
• Issue and track training records for all records, including batch records, SOPs and other miscellaneous required training
• Maintain MSDS Sheets
• WFI auditing and document maintenance
• Filing of SOPs, Product specs, RM specs and other miscellaneous filing as needed
• Log book updates and auditing
• Maintain work center logs and equipment logs in an orderly manner
• Track supplements and ensure proper closure and follow up
• Back up Admin Assistant as needed on batch record entry and other miscellaneous operations assignments
• File completed batch records and other filing as necessary. Maintain tight control of batch record fils

Qualifications/Skills

• 3 or more years of office experience
• Strong computer skills
• Manufacturing office background preferred

Education, Experience & Licensing Requirements

• High school diploma

 

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.