Sr. Specialist, Quality Assurance Compliance

Company: Avid Bioservices
Location: Tustin
Posted on: May 3, 2021

Job Description:

Avid Bioservices Inc., located in Tustin CA, is a dedicated contract development and manufacturing organization ("CDMO") focused on development and CGMP manufacturing of biopharmaceuticals products derived from mammalian cell culture. Avid provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 28 years of experience producing monoclonal antibodies, enzymes, and recombinant proteins in batch, fed-batch, and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, release and stability testing as well as regulatory strategy, submission and support. Avid also provides a variety of process development activities, including cell culture and feed optimization, analytical methods development, and product characterization.

We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today!

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Covid-19 Hiring Update: We are continuing to interview and hire during this time. Avid Bioservices' is committed to caring for the safety and well-being of applicants and employees; all interviews will be completed over the phone or virtually.

Summary:

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. 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.

Objective:

• Support the Director, Quality Assurance Compliance by conducting internal audits of Avid Operations and Quality Systems and external audits of Avid's vendors. Follow up on internal and external audit results to ensure appropriate responses during inspections
• Develop solutions to complex issues and Quality initiatives following cGMP regulations
• Perform tasks and work to achieve company goals and organizational objectives.

Essential Duties and Responsibilities include but are not limited to the following:

• Follow company policies and procedures.
• Establish work priorities to meet targets and timelines.
• 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 data, records and documents to assess appropriateness of investigation, root cause identification and corrective action activities.
• 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 systems, 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.

Technical Duties/Responsibilities:

• Review and approve quality management records.
• Participate in discrepancy investigations. Ensure discrepancies are thoroughly identified, defined and properly assessed.
• Participate in company audit readiness activities.
• Interact with interdepartmental contacts on 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.

Position Type/Expected Hours of Work:

This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m.

Qualifications:

• B.A. or B.S. degree (preferably in Life Science) and at least 5-6 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
• Ability to communicate clearly and professionally both in writing and verbally
• Skillful in problem solving and analytical thinking.
• Flexibility in work hours to meet business objectives
• Audit skill and/or certification is preferred.

EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER

Avid Bioservices, Inc. does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.

Keywords: Avid Bioservices, Tustin , Sr. Specialist, Quality Assurance Compliance, Other , Tustin, California