Biibhr
Sr Associate I, Quality Assurance Operations
Research Triangle Park, NC · Senior · Full-time
Sponsorship not specified$81k-$105kDetected 5 days ago
ComplianceExcelHRGMPResearchCommunicationCollaborationMentoringGxP
About the role
- Associate I is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.
- This individual has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally.
Responsibilities
- Batch Record Review impacting Product Disposition: Review all Quality related documents (e.g., production records, procedures, work instructions, raw data, in process testing, raw material disposition, etc.) for compliance and determine acceptability for use in GMP production activities and/or release of product for further processing and/or distribution.
- Conduct investigations and perform thorough reviews of the investigations and provide feedback to the department owner.
- Support investigations with the ability to analyze the defect and determine potential areas within the process that may have attributed to the defect.
- Controlled Document Workflows: Review of GMP controlled documents to ensure changes and reasons are accurately reflected in the workflow, content is compliant with all applicable regulations and company directives, changes will not have an adverse impact to product quality and setting appropriate release dates.
- Complete area walkthroughs and work observations to identify compliance gaps. Collaborate with Manufacturing and Area Subject Matter Experts to identify appropriate corrective actions.
- Support resolution of both technical and compliance issues/gaps of moderate complexity. Help in implementation of Quality Systems/System Improvements and technical problem solving.
- Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions.
- Support area release, changeovers and equipment release, visual inspection of equipment, shutdown activities, equipment tracking workflows, work order reviews and approvals.
Requirements
- You are task oriented and focused on continuous improvement.
- You are curious and eager to learn.
- Additionally, you have excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.
- Experience in drug substance manufacturing, biologics, and/or Contract Manufacturing Organizations (small molecule)
- Experience supporting product disposition
Nice to have
- Complete area walkthroughs and work observations to identify compliance gaps.
- Help in implementation of Quality Systems/System Improvements and technical problem solving.
- Provide some mentorship and training within and across functions.
- Other duties as assigned.
- Bachelor's Degree required, preferred in life science
- Minimum 4 years of relevant Quality experience within a GMP pharmaceutical or biotech manufacturing environment
- Experience reviewing and approving batch records
- Experience conducting and explaining investigations to quality management and regulatory bodies
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Paid Maternity and Parental Leave benefit
- 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)
- Employee stock purchase plan
- 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.
Company info
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- 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.
This listing is sourced directly from Biibhr's careers page and normalized into a canonical job model.