Sr Associate I, Quality Assurance

Job Description

TheSr. Quality Assurance Associateis responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Pharma Research Triangle Park (RTP) Drug Product Parenteral facility. Specifically, this role will have primary quality oversight of the following activities: (1) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exception’s review and approval and (3) Respond to operational needs that require QA approval.

As appropriate, the Sr. Associate may also recommend changes to existing quality systems and GMP processes (change control), identify gaps in existing quality systems, propose solutions to QA management. It is expected that this role will report directly into the QA Manager.

What You'll Do
  • Provide quality oversight during batch manufacturing.
  • Primary point of contact for issues that need immediate corrective action plans, product impact assessments and decisions with respect to batch discrepancies.
  • Responsible for compliance monitoring of the manufacturing area.
  • Reviews documents (e.g., production records, test methods, raw data, and certificates of analysis) for compliance and determines acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
  • Assesses criticality of exceptions/investigations for product impact.
  • Performs thorough reviews of the investigations and provides feedback to the department owner.
  • Collaborates with associated departments to determine the appropriate CAPA.
  • Responsible for controlling master production records and issuing working copies of these records according to the production scheduled.
  • Records are printed and verified to be accurate prior to issuance.
  • Assures compliance against applicable procedures and providing QA oversight of controlled document creation, revision, retirement, and issuance requirements.

Who You Are

You are atask driven and focused individual who is capable of taking action to resolve, remediate and/or improve quality challenges. You are collaborative and capable of being both agile and customer focused.

Qualifications

Required
  • Bachelor’s degree strongly preferred
  • Minimally 5 yrs. relevant technical experience
  • Experience in drug product batch record review
  • Experience with deviations varying in complexity as both an author and approver
  • Strong knowledge in FDA/EMA regulations and compliance

Preferred
  • Strong organizational skills; multi-task
  • Investigative mindset and solid decision making skills
  • Experience in aseptic fill/finish manufacturing operation (preferred)




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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