QA Auditor

Description

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:

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.

Key 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.
• Occasional overnight travel by land and/or air may be required to conduct audits, attend seminars or conferences.
• Perform other duties as assigned.

Minimum Qualifications:

• 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.

• Audit skill and/or certification preferred.

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 $103,200 - $129,000 annually 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.