Senior Quality Assurance Specialist

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 2,400 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 medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., 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 Senior Quality Assurance (QA) Specialist 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.

Responsibilities

• 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
• Generates procedures and forms needed for configuration changes to comply with regulatory standards and ensure adherence with the internal quality policy
• Maintains working knowledge of regulations
• Analyzes information for accuracy and compliance to internal procedure, cGMP and other regulatory guidelines.
• Represents QA function in internal and external audit activities, including performance of internal audits
• Actively participates in CAPA discussions. Capable of full edit and approval of CAPAs.
• Controlled document and record review and approval, e.g. SOP, validation, Master Batch records, analytical test records, batch records
• Develops QMS training materials and conducts training on QMS processes along with use of DMS functions as defined in respective DMS software
• Provides consultation on quality and compliance topics in areas of expertise
• 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

Qualifications/Skills

• Strong understanding of scientific concepts, principles and procedures
• Strong understanding of current FDA and xGMP regulations
• Strong knowledge of Quality Management Systems
• Strong skills with MasterControl and/or DMS applications
• Technical experience and knowledge in developing documentation workflows
• Strong knowledge and understanding of software validation principles
• Strong knowledge of regulations and SOP’s applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise
• Technical experience and knowledge in developing documentation workflows
• Strong knowledge and understanding of software validation principles
• Strong knowledge of regulations and SOP’s applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise
• Strong computer skills
• Ability to take direction from others and contributes in a team environment
• Strong problem-solving skills
• Excellent attention to detail
• Good interpersonal skills and is willing to ask questions about procedures and concepts
• Aptitude and willingness to gain more skills and knowledge
• Operates with substantial latitude for independent actions and decisions relating to technical problems and procedures
• Recognized as a technical resource in a related area
• Ability to be trained and train/ mentor others
• Expert in related technologies
• Demonstrates continued development in a relevant area of CMC and/or GMP
• Working knowledge of all relevant analytical techniques
• Ability to plan and execute GMP scale-up activities with limited input from their supervisor
• May participate with outsourcing activities related to individual research area

Education, Experience & Licensing Requirements

• Related BA/BS degree with 8 years related experience, or related MA/MS degree with 5 years related experience, or equivalent combination of education and experience.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.