Quality Assurance Project Manager

Avid Bioservices • Tustin, CA

7d

About The Position

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 Project Manager is an individual contributor who solves a variety of issues following cGMP regulations and company standards.

Requirements

• 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.
• This role is a full-time, exempt position.
• Days and hours of work are Monday through Friday, 8:00 AM to 5:00 PM unless otherwise stated by Supervisor.
• The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
• 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.
• 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.
• Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.

Nice To Haves

• B .A. or B.S. degree (preferably in Life Science).
• Minimum of 4 - 5 years of experience in the biopharmaceutical industry at the Associate level.

Responsibilities

• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Generate QA trends for client Business Review Meetings
• Collaborate with Management to establish and meet targets and timelines.
• Serve as a Quality representative on cross-functional and multi-site teams as well as routine client meetings
• Identify and recommend solutions to potential procedure, process and system gaps.
• Point of contact 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.
• Sign documents for activities as authorized and described by company policies, procedures and job descriptions.
• Track QA non routine client deliverables and ensure client QA related needs are met
• 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.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed are representative of the knowledge, skill, and/or ability required.
• The job description, shown above, is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Benefits

• 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.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager