Production Specialist

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 Production Operations Coordinator provides administrative, documentation, data management, and operational support to the Production department.

This role is responsible for maintaining accurate production records and data in SAP, coordinating the movement and review of batch records between Production and Quality Assurance, tracking operational discrepancies and metrics, and supporting inventory and documentation processes. The position plays an important role in ensuring production records are accurate, complete, and available for timely QA review and approval. The role also supports department reporting, document control, inventory activities, controlled substance recordkeeping, and pre-campaign readiness activities.

Success in this position requires a high level of attention to detail, organization, accuracy, follow-through, and the ability to work effectively with Production, QA, and other site functions in a regulated manufacturing environment. Responsibilities

• Track operator discrepancies and update the tracking spreadsheets for supervisor group.
• Perform the Data Entry functions in SAP while completing production review of batch records.
• Issuing batch records from QA to the appropriate production supervisor group.
• Delivering completed and reviewed batch records to the QA Auditor group.
• General administrative duties to support department needs
• Compile data and track metrics to support improvement efforts
• Help revise, issue and maintain documents such as Standard Operating Procedures, batch records, department spreadsheets, shipping documents, etc.
• Process and maintain any monthly, quarterly and annual department reports
• Responsible for all data entry of batch record/cleaning record information into SAP.
• Key role in site’s annual physical inventory.
• Responsible for data entry of controlled substance container records into the DEA database, maintenance of database and audit for accuracy on a quarterly basis; complete yield worksheets.
• Maintains/updates appropriate department files, including but not limited to: shift bids, and vacation schedules on an annual basis for the upcoming year budget.
• Responsible for review of…