- Review and approve discrepancy investigations including, but not limited to, deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results; ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment.
- Review and approve CAPA records.
- Ensure accuracy of records and reports, including stability reports.
- Advise production on proper documentation requirements as needed.
- Review batch production records.
- Review of Manufacturing forms and paperwork in association with Batch Production Records.
- Maintain a state of inspection readiness.
- Maintain company quality and safety standards.
- Collaborate with Management to establish and meet targets and timelines.
- Independently manage competing priorities with limited instruction.
- Serve as a Quality representative on cross-functional and multi-site teams.
- Identify and recommend solutions to potential procedure, process, and system gaps.
- Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Represent Quality Assurance on multi-disciplinary project teams.
- Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
- Perform tasks as requested by Management to support Quality oversight activities.
- B.A. or B.S. degree (preferably in Life Science).
- 4+ years of Quality experience in the biopharmaceutical industry.
- Strong knowledge of cGMP regulations.
- Strong knowledge of root cause analysis processes and tools.
- Must be able to gown for a class 10,000 cleanroom environment.
- Ability to interpret Quality standards for implementation.
- Skills to independently evaluate situations and propose potential solutions.
- You have a "bring it on" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills, unparalleled attention to detail, and unwavering commitment to Quality.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
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Sr. Specialist, Quality Assurance - Tustin, United States - Avid Bioservices
Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Quality Assurance Sr. Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards.
Minimum Qualifications:
Position Type/Expected Hours of Work:
This role is a full-time position operating Monday through Friday, 5x8 (5 days x 8 hours) schedule.
The employee must also, if instructed, have the ability to work overtime when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, equity grants, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
Who you are:
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds.
However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting.
Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
