Quality Assurance Auditor I

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 QA Auditor I supports the Quality Assurance department by performing routine internal audits, reviewing quality systems, and assisting with compliance activities to ensure adherence to GMP, regulatory requirements, and company policies. 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 CAPA initiation and review Raw Material (RM) Analytical Record - Review & Approval (combine into one) Operations Notebook Issuance Participate in quarterly internal cGMP audits Rotational coverage as an after hour QA resource Issuance & Approval Inspect and approve repackaging records All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Qualifications/Skills Strong oral and written communication skills Proficient in windows based environment including word 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, Engineering, and computer software beneficial 3 or more years of experience in manufacturing environment, preferably pharmaceuticals Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred 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. 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 CAPA initiation and review Raw Material (RM) Analytical Record - Review & Approval (combine into one) Operations Notebook Issuance Participate in quarterly internal cGMP audits Rotational coverage as an after hour QA resource Issuance & Approval Inspect and approve repackaging records All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. BS in Chemistry or a related field or equivalent industry relevant experience. Classes or education in Chemistry, Mathematics, Engineering, and computer software beneficial 3 or more years of experience in manufacturing environment, preferably pharmaceuticals Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred