Supervisor, Quality Control In-Process (Flex)

Avid Bioservices•Tustin, CA

1d•Onsite

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. 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.

Requirements

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.
Hands-on experience with analytical testing and equipment, along with drafting reports, procedures, and specifications.
Expertise in protein characterization, electrophoresis, ELISA, and chromatography.
Proficiency in aseptic techniques, LAL, and assay validations.
Solid understanding and adherence to GMPs and regulatory audits.

Nice To Haves

A "bring it on!" team player approach and an unshakable positive attitude.
Exceptional written and verbal communication skills.
Exceptional multitasking skills and unparalleled attention to detail.
Strong relationship-building capabilities.

Responsibilities

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.