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Performs quality assurance oversight for early-phase biopharmaceutical manufacturing. Reviews batch production records, manufacturing documentation, testing records, and controlled documents; supports batch and lot release, discrepancy investigations, excursion reports, inspection readiness, and quality issue resolution. Serves as a Quality representative and subject matter expert on cross-functional teams while ensuring compliance with cGMPs, SOPs, and company standards.
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 Specialist (Early Phase) is an individual contributor who will solve a variety of issues following cGMP regulations and company standards.
- Maintain a state of inspection readiness.
- Provide input to the development of personal performance goals and departmental objectives.
- Collaborate with Management to establish and meet targets and timelines.
- Serve as a Quality representative on cross-functional and multi-site teams.
- Identify and recommend solutions to potential procedure, process and system gaps.
- Provide assistance to customers in support of departmental functions.
- Participate in the design and implementation of department and cross-functional initiatives.
- Apply basic theory and technical principles to address moderately complex problems.
- Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Serve as a technical subject matter expert (SME) in support of department functions.
- Sign documents for activities as authorized and described by company policies, procedures and job descriptions.
- Review Manufacturing Batch Production Records.
- Review of Manufacturing forms and paperwork in association with Batch Production Records.
- Assist in the release of API batches and lots.
- Assist with discrepancy investigations.
- Compilation and QA Review of all records in Batch history records.
- Review of testing documentation from Microbiology and Chemistry groups.
- Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product.
- Represent Quality Assurance on multi-disciplinary project teams.
- Write and assist with excursion reports.
- Interact with interdepartmental contacts on discrepancy assessment, resolution and quality approval.
- Provide Quality oversight to internal and external customers.
- Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
- Generate departmental performance metrics for review by management.
- Perform assigned tasks and work to achieve company goals and department objectives by following company policies and procedures.
Minimum Qualifications:
- B.A. or B.S. degree (preferably in the life science disciplines).
- At least 2 years of experience in the biopharmaceutical industry.
- Knowledge of cGMPs or equivalent regulations.
- Ability to interpret quality standards for implementation.
- Skills to independently evaluate situations and propose potential solutions.
- Able to interpret quality standards for implementation.
Position Type/Expected Hours of Work:
This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $32.69 to $40.86 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- 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 and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
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 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. 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.
Avid Bioservices Tustin, California, USA Office
14191 Myford Rd, Tustin, California, United States, 92780 7020
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