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Quality Assurance Specialist

LGM PHARMA SOLUTIONS LLC

Quality Assurance Specialist

Irvine, CA
Full Time
Paid
  • Responsibilities

    LGMPharma is a leading contract development and manufacturing organization (CDMO)and provider of Active Pharmaceutical Ingredients (API). With excellent APIsourcing and supply chain expertise together with our drug product contractdevelopment and manufacturing solutions, LGM is a premier end-to-end solutionsprovider to the global pharmaceutical industry.

    We are ahigh-growth organization looking to accelerate the development andcommercialization of high-quality therapeutics worldwide. We have offices inCalifornia, Texas, Kentucky, Florida and Israel and are searching for a Quality Assurance Specialist in Irvine, CA.

    PERFORMS ONE OR MORE OF THE FOLLOWING QA SPECIALTIES:

    · Develop training plans/training curricula by job type for the site Operations and Quality departments.

    · Create and maintain a system for tracking individual employee training and training records.

    · Coordinate and monitor Supervisors’ and Managers’ proficiency and training in using the tracking tool for monitoring staff training currency.

    · Identify and assess current and future training needs through job analysis and “on the floor evaluation” (Right First Time monitoring) of operators, technicians, specialists, and analysts while executing activities against current procedures, batch records, and specifications, as applicable. 

    · Track and document concerns observed during the “on the floor evaluation” and present and share the evaluation data with site management.

    · Performs and/or assists with QA review of production records and Lab reports.

    · Investigates non-conformance and deviation reports.

    · Coordinates the stability studies including reviewing laboratory reports for accuracy and preparing statistical analyses of decay curves.

    · Review test results for and release raw materials.

    · Audits production and quality control programs, reports observed deficiencies, and contributes to establishing solutions to observations.

    · Issues batch records, checks yield and reconciliation calculations, and fiels records for easy retrieval.

    · Manages validation programs related to manufacturing equipment and processes and calibration of physical testing equipment.

    · Receives, logs, investigates, and reports on complaints and adverse events; coordinates responses with QA Manager.

    COMMON DUTIES:

    · Creates and revises standard operating procedures as necessary.

    · Assures compliance with cGMP regulations and all standard operating procedures.

    ASSOCIATED DUTIES AND RESPONSIBILITIES:

    · Assist in preparation for internal, customer and agency audits.

    · Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures.

    · Assist with raw material management systems.

    · Use of statistical process control to evaluate tends.

    · Other related duties as required.

    REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:

    · Bachelor’s degree in a scientific discipline or 4 years experience in a quality control or quality assurance function associated with manufacturing.

    · Ability to read and interpret technical procedures, SOP’s, GMP’s and governmental regulations.

    · Strong communication skills, both written and verbal.

    · Ability to effectively present information and respond to questions.