QA Auditor

Avid Bioservices•Tustin, CA

1d•Onsite

About The Position

As an individual contributor, performs a wide variety of activities to ensure compliance with applicable quality and regulatory requirements by conducting internal and external audits, data and documentation reviews and analysis. Prepares audit reports regarding compliance findings and concerns and provides recommendations for corrective actions. Coordinates resolution of quality issues with suppliers and monitors quality metrics. Serves as the QA subject matter expert in the creation and revision of Raw Material Specifications. Writes and revises SOPs. This position focuses on regulatory compliance, strict adherence to the company’s quality policy, in addition to improving and implementing cGMP practices.

Requirements

B.A. or B.S. degree (preferably in Life Science) and 5+ years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience.
Sound knowledge of cGMPs or equivalent regulations.
Ability to interpret and relate Quality standards for implementation and review.
Ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
Exceptional multitasking skills and an unparalleled attention to detail.
Master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Written and verbal skills are out of this world, and you communicate with clarity and confidence.

Nice To Haves

Audit skill and/or certification preferred.

Responsibilities

Perform independent internal and external audits for adherence to cGMPs and other relevant Federal, foreign and corporate regulations and policies.
Follow up on audit response and corrective actions.
Review vendor data, records and documents to assess appropriateness of materials and services to be used in a cGMP environment.
Process new vendor requests for the organization and independently perform qualification activities to provide recommendations to management.
Serve as the Quality Compliance representative on cross-functional teams.
Identify, design, and implement process and system improvements.
Evaluate regulatory requirement changes, impact to company’s operations and make recommendations to management.
Support client audit and regulatory inspection (FDA and Foreign) activities.
Serve as a technical subject matter expert (SME) in support of department functions.
Mentor junior personnel serving as a subject matter expert (SME) on Quality Compliance processes and issues.
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
May conduct investigations related to non-compliance matters.
Follow company policies and procedures.
Establish work priorities to meet targets and timelines.
Review and approve quality management records.
Participate in Supplier discrepancy investigations.
Ensure discrepancies are thoroughly identified, defined and properly assessed.
Participate in company audit readiness activities by identifying any systematic compliance gaps and subsequently working inter-departmentally to mitigate the risks of the gaps.
Interact with interdepartmental contacts on Supplier discrepancy assessment, resolution, and quality approval.
Provide guidance to internal and external customers on best practices for maintaining a quality program.
Ensure that the proper policies and procedures are in place.
Identify, design, and implement process improvements.
Provide input into the design and presentation of departmental performance metrics.
Perform other duties as assigned.