Specialist, Quality Assurance (Early Phase)

Avid Bioservices•Costa Mesa, CA

1d•Onsite

About The Position

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. The Quality Assurance Specialist (Early Phase) is an individual contributor who will solve a variety of issues following cGMP regulations and company standards. This role involves maintaining a state of inspection readiness, providing input to departmental objectives, and serving as a Quality representative on cross-functional teams. The specialist will identify and recommend solutions to procedural, process, and system gaps, and troubleshoot Quality issues by fostering interdepartmental partnerships. This role also requires signing authorized documents, reviewing manufacturing batch records and associated paperwork, assisting with API batch/lot release, supporting discrepancy investigations, compiling and reviewing batch history records, and reviewing testing documentation from Microbiology and Chemistry groups. Additionally, the role involves reviewing and approving controlled documents related to product manufacture, representing Quality Assurance on project teams, writing and assisting with excursion reports, interacting with interdepartmental contacts for discrepancy assessment and resolution, and providing Quality oversight to internal and external customers. The specialist will collaborate with departments to ensure efficient review activities and generate departmental performance metrics.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.