Location: Charles City,IA, USA
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. 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 (QA) Auditor is responsible for ensuring compliance with regulatory standards and internal quality requirements in the manufacturing process. This position plays a key role in maintaining product quality and safety by reviewing, auditing, and inspecting batch records, finished goods, and raw materials. Additionally, the QA Auditor will oversee several critical quality control processes, participate in internal audits, and monitor corrective and preventive actions (CAPA). Responsibilities Accountabilities and Responsibilities: In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review SAP transactions Out Of Specification, Deviation, Investigation support and review utilizing TrackWise Issuance & Approval Inspect and approve repackaging records Raw Material (RM) Analytical Record - Review & Approval Laboratory and Operations Notebook Issuance Participate in quarterly internal cGMP audits. Rotational coverage as an after hour QA resource Back up to QA Inspector for Raw Material Inspections and Sampling including WFI water samples Qualifications/Skills Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred Strong oral and written communication skills Proficient in windows based environment including work processing, spreadsheet and database programs Education, Experience & Licensing Requirements BS in Chemistry or a related field or equivalent industry relevant experience. Classes or education in Chemistry, Mathematics and computer software beneficial 3 or more years of experience in manufacturing environment, preferably pharmaceuticals 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. #LI-RD1BS in Chemistry or a related field or equivalent industry relevant experience. Classes or education in Chemistry, Mathematics and computer software beneficial 3 or more years of experience in manufacturing environment, preferably pharmaceuticalsAccountabilities and Responsibilities: In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review SAP transactions Out Of Specification, Deviation, Investigation support and review utilizing TrackWise Issuance & Approval Inspect and approve repackaging records Raw Material (RM) Analytical Record - Review & Approval Laboratory and Operations Notebook Issuance Participate in quarterly internal cGMP audits. Rotational coverage as an after hour QA resource Back up to QA Inspector for Raw Material Inspections and Sampling including WFI water samples