QA Auditor II - PQA

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Thermo Fisher’s clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree in scientific field, or equivalent with related experience.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
  In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

KNOWLEDGE, SKILLS AND ABILITIES:

• Minimum of 2 years’ experience in a cGMP-related field (Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry).
• Strong communication skills, both oral and written
• Strong computer skills using a Microsoft environment (e.g. Word, Excel, PowerPoint)
• Batch record review experience and/or material inspection experience.
• This position is accountable for compliance to site, division and corporate procedures in their work area.
• Accountable for meeting established department standards and goals.
• Accountable for reviewing production batch records and addressing related issued.
• Familiarity with MES systems (such as POMSnet) is nice to have.

• Response for on-the floor review of Production Batch Records, Worksheets and Changeover Protocols used in cGMP manufacturing facility for accuracy and GMP compliance.
• Interact with Production personnel to resolve discrepancies and deviations.
• Ensures that product within the plant is consistently manufactured in conformance with Quality System requirements and all applicable regulatory requirements.
• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Work closely with Manufacturing to ensure document changes, deviations and CAPAs are performed in compliance with SOP’s cGMP regulations.
• Review changes to documents (including, but not limited to, SOPs and batch records), following established cGMP guidelines.
• Track and trend batch record review and related issues.
• Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation, Division and Location.