About This Role
This is a full time, on-site position with a NIGHTS schedule of 6PM to 6AM on a 2-2-3 rotation
The Senior Quality Associate I is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. The QA Sr. Associate I has an advanced understanding of the Biogen Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally. The QA Sr. Associate I provides guidance regarding regulatory compliance, technical expertise, independent assessment and expert consultation to Manufacturing, Quality Control, Engineering, Validation, and other supporting departments. The QA Sr. Associate I will perform all duties in a manner consistent with site and Corporate policies, cGMP, safety, environmental and human resources policies and procedures, assist with regulatory and third party audits and aid in the development and implementation of Global Quality Systems, manage Quality projects and other initiatives, adhere to all regulatory licenses and regulations, interfacing with key Quality and Manufacturing partners, provides coordination and Quality oversight of investigations impacting clinical and commercial programs. It is expected that this role will report directly into the PF Quality Shop Floor Management.
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What You'll Do
- Ensure batch process documentation and other documents supporting the batch execution are compliant and determines acceptability for release of the product for further processing.
- Serve as a technical consultant for quality related issues and assuring compliance with regulatory requirements and site procedures. Represent Quality line function on applicable teams and leads/attends meetings as appropriate
- Report the performance of quality system to management by overseeing, tracking and communicating quality metrics
within the PF QA Shop Floor - Assess criticality of exceptions/investigations for product impact. Perform thorough reviews of investigations and determine potential areas within the process that may have attributed to the exception
- Review documents for compliance and identifies gaps in existing quality systems proposes solutions and drive cross-functional improvement initiatives
- Support the QA Leadership in the coordination of key responsibilities and deadlines pertaining to the PF QA Shop Floor
- Collaborate with and/or lead cross-functional teams to execute approved projects aimed at increasing overall quality of business
- Mentors and trains less experienced associates across Quality Assurance functions. Serves as a technical subject matter expert (SME) in support of department functions
- Approximately 70% of time in this position will be spent on the manufacturing floor
- Other duties as assigned
Required Skills
- Bachelor's Degree required, preferred in life science
- Minimum 4 years of relevant Quality experience within a pharmaceutical or biotech GMP (preferred drug product) manufacturing environment
- Advanced understanding of global quality systems applications, principles, concepts, practices and standards and GxP regulations
- Must be able to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally
- Excellent written, verbal, and interpersonal communication skills
Preferred Skills
- Experience working in an aseptic manufacturing environment
Job Level: Professional
Additional Information
The base compensation range for this role is: $79,000.00-$103,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to 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 federal, state or local law. Biogen is an E-Verify Employer in the United States.