Supervisor, Quality Control In-Process (Flex)

avidbio; Tustin (CA); On-site; USD 67,700 - 90,300; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avidbio in Tustin, California is seeking a passionate Quality Control In-Process Supervisor to lead the Quality Control Analytical Department. In this full-time position, you will manage a dedicated team, ensuring that all processes meet the highest quality standards.

The ideal candidate will have over 5 years of life science industry experience, with a strong background in analytical testing and regulatory compliance. The role offers competitive compensation between $67,700 and $90,300 annually.

Qualifications

• 5+ years of life science industry experience in a QC or analytical lab, including 1 year of supervisory experience.
• Hands-on experience with analytical testing and equipment, along with drafting reports, procedures, and specifications.
• Demonstrated understanding and adherence to GMPs and regulatory audits.

Responsibilities

• Lead the technical review and drafting of analytical data and reports.
• Monitor the progression of QC analysts and align schedules with manufacturing needs.
• Ensure maintenance and calibration of all instruments as per SOPs.
• Supervise analysts and identify training needs in compliance and troubleshooting.
• Participate in partner and regulatory audits.

Skills

Analytical testing

Protein characterization

Aseptic techniques

Electrophoresis

ELISA

Chromatography

Education

Bachelor'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:

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.