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 Within Cambrex Corporation, the Document Control Manager is part of a global quality team that creates and supports effective GxP documentation processes for all Cambrex sites across the company. This role is responsible for effective document processing, management, and multi-site support of the Cambrex Quality Management System (QMS) which includes the use of MasterControl and TrackWise for documentation, training, and quality management. As a Document Control Manager, you will manage electronic document processes (including daily maintenance, tracking, workflows, document formatting/editing, closure) to ensure adherence to company policies and procedures, regulatory requirements, and best documentation practices, with effective use of the QMS. You will coordinate with appropriate departments and/or cross-functional teams of multiple sites to ensure all applicable documents are reviewed and revised within the specified timeframes, receive proposed draft documents from originators, and perform initial review on draft documents accordingly within the QMS. This position provides timely and direct support to Cambrex site users of the QMS to resolve problems and ensure effective use of MasterControl and TrackWise. Responsibilities + Reports to the Cambrex Senior Manager of the Cambrex Quality Management System (QMS). + Ability to work in a fast-paced environment while managing multiple tasks or projects. + Works with Quality Management at all Cambrex sites to ensure that documents are properly processed and maintained in MasterControl and TrackWise. + Provide related QMS support and assistance for internal and external audits of Cambrex sites. + Train new hires and assist with QMS retraining as required, one-on-one; group sessions; remote or classroom environment. Evaluate training effectiveness and remedy deficiencies. + Directly engaged in providing routine user support to all Cambrex QMS users in resolving basic to complex problems, issues, and related troubleshooting. Qualifications/Skills + 5 or more years of relevant pharmaceutical industry experience is required + Previous experience with regulated document control in a multi-site organization and with direct experience in electronic document management systems. + Relevant experience with an electronic QMS (MasterControl and/or TrackWise are a plus) for documentation and training support is required. + Demonstrated experience as a system manager or administrator in the MasterControl and/or TrackWise platform required. + Experience using Microsoft Office applications (Word, Excel, PowerPoint), email, etc. + Effective communication and presentation skills with ability to train co-workers with varied educational backgrounds and experiences with controlled documentation. + Strong attention to detail, teamwork, organizational and workload planning skills Education, Experience & Licensing Requirements + Associates or Bachelor's Degree preferred OR equivalent work experience 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.