Band 5 Compliance Specialist II

Thermo Fisher Scientific • Plainville, MA

1d • $67,400 - $101,150 • Onsite

About The Position

The Compliance Specialist II supports manufacturing compliance for Pharma Services, Viral Vectors, at the Plainville, Massachusetts facility. The role is 100% onsite in a standard office environment, with some interaction in GMP manufacturing and laboratory settings. It leads and owns manufacturing investigations, uses root cause analysis tools to identify causes and contributing factors, supports consistent manufacturing and quality standards for Deviations and CAPAs, and manages complex document revisions, including batch production records and manufacturing procedures.

The position conducts GxP deviation investigations, assesses event impact, communicates findings, and defines or supports corrective and preventive actions in alignment with Manufacturing requirements. It collaborates with Manufacturing and supporting groups, supports internal and external observations, change control, and compliance priorities, and contributes to continuous improvement and client or planning meetings. The role may involve occasional standing, walking, and PPE use during client visits or facility tours.

Requirements

• Minimum high school diploma with 6–8 years of industry-related experience; alternatively, 4–6 years of industry-related experience with an associate degree, or 2–4 years with a bachelor's degree.
• 2–4 years of BioPharma deviation investigation experience.
• Strong interpersonal and written and oral communication skills.
• Skill using a personal computer and related software applications.
• Ability to work effectively with a wide range of constituencies in diverse areas.
• Skill in meetings and interviews to elicit technical details from subject matter specialists.
• Ability to communicate effectively in writing or verbally with peers, senior associates, and area management within the operational group.
• Ability to develop logical structures for technical documents, content, and illustrations.
• Detail-oriented proofreading skills.
• Ability to recognize situations requiring further evaluation and report process, safety, personnel, or other events to senior specialists or area management.
• Ability to understand operational documents for GMP compliance, accuracy, and completeness.
• Ability to gown aseptically and/or wear sterile gowning as needed.
• Ability to write, read, and review written documentation for extended periods.
• Ability to function in a fast-paced, dynamic environment while managing multiple priorities.
• Strong planning, organization, and multitasking skills.

Responsibilities

• Conduct and assemble GxP deviation investigations.
• Identify event impact and communicate or present findings to Manufacturing and Quality.
• Define, own, and/or support corrective and preventive actions (CAPAs) in alignment with Manufacturing requirements.
• Use manufacturing process knowledge and investigative skills to resolve manufacturing issues and drive continuous improvement in process operations.
• Edit cGMP documents and process them through workflow for quality approval.
• Collaborate cross-functionally with Manufacturing and other supporting groups.
• Support Manufacturing during internal and external observations, as required.
• Practice and promote safe work habits while adhering to safety procedures and guidelines.
• Support and develop consistent manufacturing and quality standards or processes for Deviations and CAPAs in Quality Systems.
• Support document revisions and document management, including batch production records and manufacturing procedures.
• Own and maintain tracking systems for manufacturing compliance priorities.
• Work collaboratively to meet group and organizational goals.
• Participate in innovation and continuous improvement initiatives.
• Improve compliance with quality procedures, policies, and regulations.
• Participate in client and planning meetings as requested, including presentation and document preparation.
• Support Manufacturing change control.

Benefits

• Variable annual bonus may be available based on company, team, and/or individual performance, in accordance with company policy.
• 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 of paid time off (PTO) and 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.
• 401(k) U.S. retirement savings plan.
• Employee Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED