Job Title: Manufacturing Quality Specialist
Location: Houston, TX, 77047
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Pay Rate: $40 to $48 per hour
Overview:
TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Responsibilities:
- Lead Quality Council and Quality Management Systems program
- Facilitates the implementation of clients quality systems and compliance initiatives projects at the site
- Identifies, maintains and reports site quality KPIs for Quality Council
- Responsible for ownership of the site’s Quality Council program, including hosting and ensuring participation of SMEs in monthly Quality Council meetings
- Reports site quality KPIs in client’s KPI reporting system monthly
- Identifies actions required to meet site KPI targets and facilitates with SMEs activities necessary to meet those targets
- Supports and hosts change controls review board, deviation review board and CAPA review board.
- Responsible for site monthly and quarterly trending program and associated reports
- Identifies and facilitates execution of CAPAs related to identified trends
- Revise or approve quality records (change controls, deviations/ investigations, CAPAs and controlled documents-SOPs, forms, etc., related to compliance or risk management program.
- Perform other duties as assigned
Qualifications:
- Key requirements: Minimum 5 years’ experience
- cGMP environment and related QA field
- Must have KPI and/or KQI experience
- Must have TrackWise experience
- Must be proficient in Excel
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
