FSP QA Auditor II

Thermo Fisher Scientific • Worcester, MA

1d • $26 - $38 • Onsite

About The Position

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.

Requirements

• 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 2-4 years)
• Minimum of 2 years’ experience in a cGMP-related field (Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry).
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• Must have some knowledge of plant and company level procedures.

Nice To Haves

• Quality Assurance/Regulatory Affairs/Compliance is preferred

Responsibilities

• Supports the Quality Function that they are responsible for within GMP Operations.
• Review and releasing of raw materials and supporting raw material testing.
• Ensure that all products, processes, or system related quality activities related to raw material inspection and suppliers are in compliance with Corporate and governmental regulations.
• Responsible for various aspects of quality assurance related to their functional area.
• Review and release raw materials for use in production facility.
• Provide support for raw material testing.
• Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc.
• Ability to identify and investigate problems and help to resolve them.
• Support trouble shooting and resolutions of quality compliance issues.
• Assist with drafting raw material specification documents.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level