Band 5 Compliance Specialist II

Work Schedule

Environmental Conditions

Job Description

Pharma Services |Viral Vectors | 5 Commerce Drive, Plainville, MA |100% Onsite Days

How will you make an impact?

This role makes an impact by leading and owning manufacturing investigations; utilizing root cause analysis tools, as required, to identify root causes and contributing factors; supporting and developing consistent manufacturing/quality standards and processes for Deviations and CAPAs in Quality Systems; and conducting complex document revisions and/or document management, including batch production records and manufacturing procedures.

Responsibilities:

• Investigation / CAPA
• Conduct and Assemble GxP Deviation Investigation
• Identify event impact and communicate/present findings to Manufacturing and Quality.
• Define, own, and/or support corrective and preventive actions (CAPAs) in alignment with Manufacturing requirements.
• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations.
• Edit cGMP documents and process them through workflow for creation of quality-approved documentation.
• 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.
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• Support and develop consistent manufacturing/quality standards and/or processes for Deviations and CAPAs in Quality Systems.
• Support document revisions and/or document management, including batch production records and manufacturing procedures.
• Own and maintain tracking systems for manufacturing compliance priorities.
• Work collaboratively with others to meet group and organizational goals.
• Participate in initiatives that support innovation and continuous improvement activities.
• 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.

• Education:

  Minimum High School Diploma required with 6–8 years’ industry related experience 4–6 years’ industry related experience with an Associate’s Degree 2–4 years’ industry related experience with a Bachelor’s Degree Strong interpersonal and communications skills; written and oral.

• Experience

  2-4 years of BioPharma Deviation Investigation Experience

• Knowledge, Skills, Abilities

  Must be skilled in the use of a personal computer and related software applications. Must have strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in diverse areas. Must be skilled in meetings and interviews to eliciting technical details from subject matter specialists. Must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group. Must be able to develop logical structure for technical documents, content and illustrations. Must be detail oriented while proofreading documents. Must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc.) to senior specialists or area management. Must be able to understand operational documents for GMP compliance, accuracy and completeness.•  Ability to gown aseptically and/or sterile gown as needed.•  Ability to write, read, and review written documentation for extended periods of time.•  Ability to function in a fast-paced, dynamic environment with multiple priorities simultaneously.•  Strong planning, organization, and multitasking skills.•  Strong interpersonal and communication skills, with the ability to work effectively with a wide range of constituencies in a diverse community.

• Work Environment/Physical Requirements

  Standard office environment with some interaction in GMP manufacturing and laboratory settings.May require occasional standing, walking, and use of PPE during client visits or facility tours.This role is based 100% onsite at the Plainville, MA facility.

Compensation and Benefits

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