Supervisor, Quality Control In-Process (Flex)

Posted Yesterday
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Tustin, CA, USA
In-Office
68K-90K Annually
Senior level
Healthtech • Pharmaceutical
Transforming the CDMO experience: Unrivaled expertise. Worldclass facilities. Exceptional quality. Personalized process.
The Role
Supervise the Quality Control In-Process group supporting biopharmaceutical manufacturing. Lead technical review and drafting of analytical data, reports, SOPs, and test methods; manage schedules, analyst development, training, instrument maintenance, calibrations, compliance, documentation, and investigations. Support regulatory and partner audits, continuous improvement, and cross-functional manufacturing needs while ensuring adherence to cGMP requirements.
Summary Generated by Built In

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 the Quality Control In-Process Supervisor, you’ll be stepping into a dynamic leadership role, where you spearhead the daily ventures of the Quality Control Analytical Department's In-Process group. Under your watchful eye, your dedicated team will flourish as you nurture their performance and professional growth, paving the way for the department and organization to achieve and surpass their goals. Your robust technical acumen and GMP experience will be the cornerstone of success, empowering you to pioneer and drive forward continuous improvement initiatives. This is your opportunity to lead, inspire, and make a tangible impact, ensuring the highest standards of quality are not just met, but exceeded.

  • Lead the technical review and drafting of analytical data, technical reports, SOPs, and Test Methods, covering a range of assay methodologies like LAL, UV Spec Scan, pH, USP compendia, HPLC, and ELISA.
  • Monitor and foster the progression of QC analysts and teams towards departmental goals, while devising QC schedules to align with manufacturing and client support needs.
  • Ensure maintenance, calibration, and routine performance verifications of all instruments as stipulated in respective SOPs.
  • Supervise analysts, identifying training needs, and facilitating comprehensive training in regulations, compliance, and instrument troubleshooting.
  • Uphold stringent adherence to regulatory compliance, cGMPs, and ensure accurate documentation, billing, and timesheet approvals.
  • Lead or designate leads for laboratory assessments and investigations related to out of specifications and out of tolerance results, engaging with cross-functional teams to ensure robust QC support.
  • Participate in partner and regulatory audits, while executing additional duties as assigned, showcasing a steadfast commitment to quality and organizational objectives.
  • Perform other tasks as needed.

Minimum Qualifications:

  • Bachelor's Degree in Chemistry or Biology.
  • 5+ years of life science industry experience in a QC or analytical lab, inclusive of 1 year of supervisory experience.
  • Have hands-on experience with analytical testing and equipment, along with drafting reports, procedures, and specifications.
  • Showcase expertise in protein characterization, electrophoresis, ELISA, and chromatography.
  • Demonstrate proficiency in aseptic techniques, LAL, and assay validations.
  • Exhibit a solid understanding and adherence to GMPs and regulatory audits.

Position Type/Expected Hours of Work:

  • Adaptable schedule to accommodate operational and scheduling demands.
  • Availability for overtime and weekend shifts as necessary.
  • This role is a full-time onsite position operating on a Sunday through Wednesday or Wednesday through Saturday 4x10 (4 days x 10 hours) schedule, with operating hours from 5:00pm to 4am. Must have the ability to work overtime, weekends and/or holidays 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 $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 great at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Work Environment & Physical Demands:
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.

Skills Required

  • Bachelor's degree in Chemistry or Biology
  • 5 or more years of life science industry experience in a quality control or analytical laboratory
  • At least 1 year of supervisory experience
  • Hands-on experience with analytical testing and laboratory equipment
  • Experience drafting reports, procedures, and specifications
  • Expertise in protein characterization, electrophoresis, ELISA, and chromatography
  • Proficiency in aseptic techniques, LAL, and assay validations
  • Understanding of and adherence to GMPs and regulatory audits
  • Ability to work onsite on a 4x10 evening schedule, including overtime, weekends, and holidays as needed

Avid Bioservices Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Avid Bioservices and has not been reviewed or approved by Avid Bioservices.

  • Healthcare Strength Health coverage includes medical, dental, and vision alongside life and disability insurance. Plan breadth is presented as solid, with health benefits frequently highlighted as a strong element of the package.
  • Equity Value & Accessibility An Employee Stock Purchase Plan with a discounted purchase feature and the availability of stock grants provide accessible ownership opportunities. These components add long-term value beyond base pay.
  • Fair & Transparent Compensation Pay ranges are posted for some roles, offering upfront clarity on expected compensation. This transparency supports clearer expectations during hiring.

Avid Bioservices Insights

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The Company
HQ: Tustin, California
343 Employees
Year Founded: 2002

What We Do

Avid Bioservices is transforming the CDMO experience, with more than 30 years of unrivaled experience manufacturing biologics, and world-class mammalian protein facilities. We’ve produced more than 250 commercial batches, and 5 commercial products marketed in 90+ countries. For more than 10 years, we’ve maintained a flawless quality track record which we’re committed to uphold. We do it right the first time, which saves money and time. From early-stage to late-stage, concept to market, every part of our process is personalized. We’re your advocates, your trusted experts, your true partners.

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