Biopharma Exception Report Investigation Author

4 weeks ago

Worcester, United States AbbVie Full time

**Company Description**

The Sr Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

**Responsibilities**:

- Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products.
- Assist project teams in planning, preparation, review and approval of quality documentation.

Responsible for developing a process to maintain citation history.

Monitor changes to legislation, regulations and statutes that may impact retention and/or require changes to the AbbVie Record Retention Schedule.
- Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
- Complete and route change requests for process document creation, maintenance, and implementation.
- Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
- Interact with internal and external partners for development of best practices in our quality systems and procedures.
- Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
- Contribute and prepare training and education programs for various aspects of quality assurance.

**Qualifications**
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
- 5+ years’ experience in quality assurance, quality oversight or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
- Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
- Strong oral (with all levels of management) and written communication skills needed.
- Excellent interpersonal skills a plus.
- Runs and manages small to medium sized quality related projects.

**Additional Information**
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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