Specialist, Quality Assurance (Early Phase)

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: