Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.
The QA Specialist I supports the Quality Management System (QMS) and the Document Management System (DMS) in a GMP regulated environment according to established operating procedures. The QMS and DMS functional areas include but are not limited to: Document Control, Training, Deviations, Out of Specification Investigations, Corrective and Preventive Actions (CAPA), Change Control, Complaints, Quality review of analytical and microbiological data and batch production records, Internal Audits, Supplier/Subcontractor Management, Validation, and Calibration & Maintenance.
- Provides quality evaluation and release of support materials, products, equipment and facilities
- Maintains quality databases and may perform analysis and trending
- Assists with quality improvement initiatives as needed
- Supports the DMS including revising and effective dating documents, assisting with training curriculums and providing end user support.
- Performs internal audits
- Maintains working knowledge of regulations
- Analyzes information for accuracy and compliance to internal procedure, cGMP and other regulatory guidelines.
- Controlled document and record review, e.g. SOP, validations, analytical test records
- Review of master batch records and executed batch records
- Effectively performs a variety of duties on schedule, with accuracy and competency
- Maintains accurate files and records
- Complies with company policies and SOPs; performs assigned tasks carefully and on schedule according to SOPs.
- Performs other duties as assigned
- Related BA/BS degree with 0-2+ years experience or equivalent.
- Communicate clearly and effectively both orally and in writing with clients and other employees.
- Goal-oriented, with ability to prioritize and manage multiple tasks and numerous projects in a fast-paced environment.
- Strong problem-solving abilities.
- Good understanding of GMP / GLP policies and regulations
- Knowledge of basic concepts, practices and procedures
- General knowledge of chemistry and scientific calculations
- Must have understanding of Quality Management Systems
- Good skills with MasterControl and/or DMS applications
- Technical experience and knowledge in developing documentation workflows
- Working knowledge and understanding of software validation principles
- Good knowledge of regulations and SOP’s applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
- Basic computer skills
- Ability to take direction from others and contributes in a team environment
- Attention to detail
- Ability to review, compile, and analyze information to prepare reports
- Good interpersonal skills and is willing to ask questions about procedures and concepts
- Aptitude and willingness to gain more skills and knowledge