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QA Specialist

QA Specialist

Cambrex CorporationWaltham, Massachusetts, US
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Job Description

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.

Snapdragon Chemistry was acquired by Cambrex in 2023 due to its innovative approach to chemical development and is now fully integrated into Cambrex. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in process development and advanced continuous manufacturing technology for traditional small molecules and complex-synthetics. At Snapdragon Chemistry, we strive to create an environment of innovation and excellence where mutual respect and teamwork underpin our culture. Snapdragon Chemistry, Inc. is a leader in chemical process development with expertise in continuous flow and process intensification technologies. Our company is catalyzing the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where synthetic chemistry underpins product development. We rely on our most valuable resource – our people – to maintain a leadership position in this market. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in pharmaceutical process development while also cultivating and furthering your career.

Job Overview

Snapdragon Chemistry is currently seeking exceptional candidates for its Quality Assurance Specialist position. A successful candidate, reporting to the Quality Assurance Manager, will be joining a highly innovative and entrepreneurial team of engineers and scientists seeking to advance pharmaceutical development and manufacturing.

The QA Specialist will play a key role in supporting Snapdragon Chemistry's Quality Management System (QMS) and GMP operations. This role involves oversight of document control, training compliance, equipment lifecycle documentation, batch record review, lot disposition, and ongoing support for manufacturing and quality initiatives. The ideal candidate will ensure GMP standards are upheld across all stages of production and documentation.

We are looking for candidates who have a passion for the science of pharmaceutical manufacturing and excited to share the Snapdragon vision of future manufacturing. The ideal candidate will have at minimum a BS degree in scientific discipline and pharmaceutical quality assurance experience.

Responsibilities

  • Support the Quality Assurance function at Snapdragon Chemistry, a Cambrex company, to ensure compliance with cGMP and internal quality standards.
  • Maintain and manage the Quality Management System (QMS) to meet regulatory and internal procedural requirements.
  • Support document control activities including issuance, revision control, archival, and retirement of controlled documents.
  • Oversee the training management system by ensuring training assignments are current and tracked for all applicable personnel.
  • Assist with equipment lifecycle management, including initiation, qualification, and periodic review of equipment.
  • Generate periodic reports and trend quality system data to support audits, inspections, and management reviews.
  • Coordinate issuance of lot numbers and Master Batch Records (MBRs) to support GMP manufacturing activities.
  • Review raw material documentation, batch records, and analytical data to ensure compliance and completeness.
  • Perform lot disposition activities, including review and reconciliation of batch records, deviations, investigations, out-of-specification (OOS) reports, and preparation of final QA disposition documentation for client delivery.
  • Facilitate release of manufacturing suites both pre- and post-cleaning for GMP operations.
  • Coordinate in-process GMP document reviews with clients and manage client approval workflows.
  • Interface with clients during audits, document reviews, and to address quality-related questions during project execution.
  • Manage laboratory notebook lifecycle, including issuance, tracking, collection, auditing, and archival.
  • Ensure compliance with data integrity principles (ALCOA) in lab documentation practices.
  • Support execution of client and vendor qualification programs, including coordination of qualification documentation and audit activities.
  • Assist with internal and external audit preparation, document retrieval, and audit responses.
  • Participate in continuous improvement initiatives focused on enhancing quality systems and operational workflows.
  • Assist with onboarding and QA training for new personnel.
  • Perform other QA-related duties as assigned by QA leadership.

    • Qualifications / Skills

  • 1-3 years QA experience including managing GMP quality systems in the Pharma / Biotech industry.
  • Knowledge of cGMP requirements for small molecule development and manufacturing a plus.
  • Experience with industry Quality Management System (QMS) software.
  • Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines.
  • Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively.

    • Education, Experience & Licensing Requirements

  • BS degree in a scientific discipline

    • 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.

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