Supervisor, Quality Control

Avid Bioservices; Tustin (CA); On-site; USD 67,000 - 91,000; Full time

Job summary

Avid Bioservices is seeking a Supervisor for the Quality Control department. This full-time role involves leading a team to ensure compliance with cGMP and regulatory requirements while overseeing raw material testing. The ideal candidate will possess a degree in Chemistry or Biology, strong technical skills, and a wealth of experience in quality control.

Benefits

Health, dental, and vision insurance

401(k) matching

Paid time off

Performance-based bonuses

Opportunities for career growth

Supportive work environment

Qualifications

• Minimum of 5 years of life science industry experience.
• Experience with GMPs and regulatory audits.
• 1-2 years of supervisory experience preferred.

Responsibilities

• Supervise the Quality Control Raw Materials group and ensure compliance with cGMP.
• Review analytical data and write/revise raw material specifications.
• Plan and create QC schedules to accommodate manufacturing support.

Skills

GMP experience

Strong technical skills

Analytical testing

Experience with raw material testing

Regulatory compliance

Education

B.S. degree in Chemistry or Biology

Job 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:

The Supervisor, Quality Control provides leadership and oversees the day-to-day operations of the Quality Control Raw Materials group. The position will supervise the performance and development of direct reports to ensure organization and department goals are met. The Supervisor, Quality Control must have strong technical skills and GMP experience and extensive knowledge of raw material compendia. They will lead and support continuous improvement initiatives,perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results.

• Review analytical data for the sampling, testing and release of raw materials.
• Assess/review raw material classifications and testing requirements.
• Write/revise raw material specifications.
• Monitor progress of individuals and teams of QC analysts toward departmental goals.
• Plan and create QC schedules to accommodate manufacturing support and client support.
• Ensure that all instruments are calibrated and that performance verifications and routine maintenance are performed on a routine basis as stipulated in the respective SOPs.
• Supervise analysts in their work assignments and identify needs for further training.
• Ensure adherence to regulatory compliance and cGMPs.
• Provide reviews and feedback including evaluations and ensure correct billing of time and materials to clients.
• Approve the timesheets of all reports.
• Facilitate or coordinate training for QC personnel in the areas of regulations and compliance.
• Ensure thorough and proper documentation of activities in respective logbooks and complete reviews.
• Perform instrument troubleshooting and train QC personnel in existing methods and instruments.
• Lead or designate a lead for laboratory assessment and investigations related to out of specifications and out of tolerance results.
• Interact with internal customers from cross-functional groups such as product development, manufacturing, quality assurance and research and development to ensure adequate QC support for those groups.
• Be responsible for thorough knowledge of cGMP and regulatory requirements and ensure compliance.
• Assess vendor change notifications (VCN).
• Assess compendial changes.
• Interface with contract testing labs.
• Interface with the client to discuss raw material specifications/qualifications.
• Perform other duties as assigned.

Minimum Qualifications:

• B.S. degree in Chemistry or Biology.
• Minimum of 5 years of life science industry experience in a QC or analytical lab
• Experience with the following is essential: raw material testing and release, analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits.

Preferred Qualifications:

• 1-2 years of supervisory experience.

Position Type/Expected Hours of Work:

This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. unless otherwise stated by Supervisor. Must be available to work holidays, weekends, or extended hours to support QC schedule.

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 $67,700 - $90,300 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 20 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.