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Associate III, Quality Assurance (Swing Shift)

Company: Biogen
Location: Durham
Posted on: November 20, 2020

Job Description:

Company Description

Job Description

*Please note that this is a Swing Shift position and will work a traditional "2-2-3 Manufacturing Rotation from 12pm-12am, on a 12hr/shift schedule”

The Quality Assurance Associate III is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include, but are not limited to: review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management. The QA Associate III will perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers, and coordination of investigations impacting the RTP site. The QA Associate III may participate in internal compliance audits; assess and approve discrepancies from site, corporate, and regulatory guidance. The QA Associate III will also support the Supervisor/Manager for activities related to interviewing and training of employees, as well as compliance with training policies.

Review and approval of batch related documentation (cGMP procedures, Master Production Records, Solution Lot records, protocols, and reports) to support product disposition

Executes activities including intermediate technical writing, intermediate investigation support (root cause analysis/impact assessment), project representation (moderate or advanced complexity)

Supports resolution of both technical and compliance issues/gaps of moderate complexity. Aides in implementation of Quality Systems/System Improvements with some guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas

Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen

Maintain cross-departmental interaction with peers to ensure timely communication of issues, support Quality and Manufacturing initiatives, and maintain harmonization of procedures, as appropriate

Interact with peers in all departments/sites with the purpose of coordination of disposition activities, investigations, discussions pertaining to strategic initiatives and compliance-related issues.

Control and release of equipment from maintenance, validation, change control and product changeover

Supports and/or assists in GxP quality systems-related training. Provides some mentorship and training within and across functions

Qualifications

General understanding of relevant FDA/EMA regulations.

Plans schedules and arranges own activities when accomplishing objectives.

Must be able to deal with ambiguity.

Advance understanding of Quality concepts; able to practice and implement them

Ability to develop innovative/creative solutions to issues of moderate complexity.

Detail oriented aptitude.

General understanding of the manufacturing process.

Excellent oral and written communication skills

Education: BA/BS in Arts/Life Sciences with 5-7 years of relevant industry experience or Masters/MBA with 3-5 years of experience in pharmaceutical manufacturing environment.

Additional Information

*Please note that this is a Swing Shift position and will work a traditional "2-2-3 Manufacturing Rotation from 12pm-12am, on a 12hr/shift schedule”

The Quality Assurance Associate III is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.

Keywords: Biogen, Durham , Associate III, Quality Assurance (Swing Shift), Other , Durham, North Carolina

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