SUPERVISOR, QUALITY ASSURANCE

LGM Pharma, LLC•Irvine, CA

50d•$90,000 - $105,000

About The Position

This role involves assisting in the supervision of various quality programs, managing the site's compliance profile, and driving continuous improvements. The position requires reviewing and approving protocols, reports, manufacturing processes, and GMP documentation. It also involves improving quality sub-systems, assisting with regulatory inspections, and leading investigations and root-cause analyses.

Requirements

Bachelor’s Degree, preferable in a scientific discipline.
6+ years of experience in Quality Assurance in a GMP facility, including people management and/or equivalent combination of education and experience.
Strong commitment to quality standards with leadership and management skills.
Ability to read and interpret technical procedures, SOP’s, GMP’s and governmental regulations: 21 CFR 111, 11, 210, and 211.
Strong communication skills, both written and verbal.
Possess positive qualities of effective leadership, staff motivation and conflict resolution.
Strong knowledge of validation, investigations, application of audit principles, concepts and practices related to a regulated quality system is required.

Nice To Haves

ASQC quality certifications, ISO 9000 or other Audit training preferred.
Strong solid dose manufacturing quality compliance experience is preferred.

Responsibilities

Assist in supervision of various quality programs such as but limited to labeling, GMP training, compliance, document control, information tracking, and equipment calibration.
Manages or assists in the compliance profile of the site and drives continuous improvements, QRB and metrics.
Review and approve protocol/reports for various qualifications and validations.
Uses statistical process control to evaluate trends. Provide periodic KPI trend reports to senior management as required.
Review and approve Manufacturing, Packaging, and Quality Operation Processes, and GMP documentation.
Approve Master Labels and Finished Product C of A’s. Assist with creation, revision and approval of SOP’s. Review and approve change controls.
Improves and/or develops comprehensive quality sub-systems (e.g., corrective/preventative action, MRB, customer complaints, vendor management programs, etc.).
Assist Senior Management during inspections by FDA, DEA, and other regulatory agencies and customers.
Helps in establishing raw material and finished product specifications based on regulatory requirements and customer needs.
Lead investigation activities, perform root-cause analyses, and develop corrective and preventative action plans.
Assist in preparations for Annual Product Review.
Comply with cGMP regulations and follow all standard operating procedures.
Other related duties as required.