FSP QA Auditor II

ThermoFisher Scientific; Worcester (MA); On-site; USD 36,000 - 52,000; Full time

Benefits offered by this job

401(k) plan

Employee stock purchase plan (ESPP)

Job summary

Thermo Fisher Scientific in Massachusetts is seeking an IQA Specialist to support GMP operations by reviewing and releasing raw materials and assisting raw material testing, ensuring compliance with Corporate and governmental regulations. This role sits within our Analytical Services team and offers full-time benefits and opportunities to grow in quality assurance and regulatory affairs.

You will work with CFR/MCA/DEA knowledge to evaluate quality across production areas and help resolve

Qualifications

• Bachelor's Degree in scientific field or related experience.
• 2+ years in a cGMP-related field (Manufacturing, QA, QC, R&D).
• Knowledge of CFR, MCA, DEA regulations is preferred.

Responsibilities

• Review and release raw materials for use in production facility.
• Provide support for raw material testing and related quality activities.
• Evaluate quality, production and support areas for GMP compliance.

Skills

cGMP experience

Quality Assurance

Regulatory Affairs

Compliance

Problem solving

Education

Bachelor's degree in scientific field

Tools

Viva

OneTrack

Job description

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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.

Key responsibilities

• The IQA Specialist supports the Quality Function that they are responsible for within GMP Operations. This includes review and releasing of raw materials and supporting raw material testing. This position will 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.

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 2-4 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).
• Quality Assurance/Regulatory Affairs/Compliance is preferred
• 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.
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• Must have some knowledge of plant and company level procedures.
• 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.

Preferred Experience

• Incoming QA - receipt, review, release of raw materials into manufacturing operations. In addition, any experience revising raw material specifications.
• Supplier QA - experience in management of an Approved Supplier List, including supplier change notifications, audit assessments, and supplier records. Previous knowledge of Viva / OneTrack is a plus.

Working Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $25.60–$38.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.