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We are currently seeking a QA Supervisor for our Erlanger, KY facility. Please note that this is an onsite position.

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

We are a high-growth organization looking to accelerate the development and commercialization of high-quality therapeutics worldwide. We have offices in California, Texas, Kentucky, Florida and Israel.

PRIMARY DUTIES AND RESPONSIBILITIES:

Supervise the daily activities in the warehouse to ensure efficient flow of materials and timely completion of Quality Assurance duties.

General oversight of systems for labeling, GMP training, compliance, document control, information tracking, and equipment calibration.

Lead investigation activities perform root-cause analyses, and develop corrective and preventative action plans.

Assist in preparations for Annual Product Review, and internal and external audits and inspections.

Develop and maintain appropriate document storage and retrieval systems.

Assist with the review and approval for original and/or revised distribution and Quality Operation Processes, and GMP documentation.

Assist with approval of SOP’s.

Provide periodic trend reports to senior management as required.

Assist Head of Quality to assure timely closure of audit items.

Provide reports from QA and data to support other business functions, as needed.

Ensure Deviations, CAPA and Change Controls are managed in a timely manner.

Support the customer complaint process and respond to Customer complaints as required.

Other related duties as required.

QUALIFICATIONS:

Bachelor’s degree in a scientific discipline.

5 years of experience in Quality Assurance in a GMP regulated manufacturing environment, or equivalent combination of education and experience.

Experience leading or supervising others in a GMP regulated manufacturing environment preferred.

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

Strong communication skills, both written and verbal.

Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.

Strong attention to detail.

ASQC quality certifications, ISO 9000 or other Audit training preferred.