Production Specialist

Job 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 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 operations batch records/cleanout records prior to QA approval to assure accuracy. · Disposals of samples from the SAP system. · Inventory removal from WWTP on the SAP system. · Scanning of batch records before QA review. · Assist with pre campaign start up/batch readiness tasks as directed. · Enter and maintain machine time entries (CORR) for designated areas. Qualifications/Skills Strong computer skills with proficiency in Microsoft Office, particularly Excel, Word, and Outlook. Ability to accurately enter, retrieve, and maintain information in SAP or similar enterprise systems. Ability to work with spreadsheets, databases, and electronic records. Strong data entry skills with a high degree of accuracy. Ability to review detailed technical and production documentation for completeness, accuracy, and consistency. Ability to perform basic calculations, data reconciliation, and yield calculations. Ability to learn and accurately apply departmental procedures and regulatory requirements. Strong organizational and document management skills. Education, Experience & Licensing Requirements 2+ years of administrative, data entry, production support, manufacturing, quality, or related experience preferred. Experience working with electronic databases, ERP systems, or document management systems preferred. Experience working in a manufacturing, pharmaceutical, chemical, food, or other regulated environment preferred. Experience working with SAP or a similar ERP system preferred. Experience working with production records, batch records, inventory records, or other controlled documentation preferred. Experience working with spreadsheets and data tracking preferred. High school diploma or GED required. Associate degree in Business Administration, Operations, Manufacturing, Supply Chain, Information Systems, or a related field preferred. Ability to wear required PPE (steel-toe shoes, safety glasses, fire-retardant clothing). Physical ability to occasionally lift up to 25 Regularly sit, stand, bend, reach, and move throughout the Comfortable working in a production/lab environment with potential exposure to: Dust, odors, noise, fumes, and varying temperatures. 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.