Posted in Engineering 30+ days ago.
This job brought to you by Professional Diversity Network, Inc
Type: Full Time
Location: Research Triangle Park, North Carolina
SummaryThe Quality Assurance Associate II (Small Scale Factory QA), 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.Job DescriptionActivities 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 II 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 II may participate in internal compliance audits; assess and approve discrepancies from site, corporate, and regulatory guidance. The QA Associate II will also support the Supervisor/Manager for activities related to interviewing and training of employees, as well as compliance with training policies.
Note: Candidates must be open to work day, swing and night shift plus weekends based on business needs.
1. Review and approval of batch related documentation (cGMP procedures, Master Production Records, Solution Lot records, protocols and reports) to support product disposition
2. Executes activities including; intermediate technical writing, intermediate investigation support (root cause analysis/impact assessment), project representation (moderate complexity)
3. 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
4. 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
5. Control and release of equipment from maintenance, validation, change control and product changeover
6. Supports and/or assists in GxP quality systems-related training. Provides some mentorship and training within and across functions
#LI-POT7Qualifications* 2-4 years directly related to position responsibilities
* General understanding of relevant FDA/EMA regulations.
* Plans schedules and arranges own activities when accomplishing objectives.
* Must be able to deal with ambiguity.
* General 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 skillsEducationBachelor of Arts/Science Degree in Life Science or other technical discipline preferredAll individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations