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Job summary
A consulting firm is looking for a quality assurance leader in Alvarado, Texas. Candidates should have over 7 years of experience in FDA-regulated consumer products and 5 years in leadership roles. Responsibilities include managing teams focused on quality improvement and overseeing inspections of ingredients and finished products. A Bachelor’s in engineering or a related field is required, with a Master’s preferred. Strong knowledge of cGMP, quality audits, and relevant tools is essential for success.
Qualifications
7+ years of experience in FDA-regulated consumer products, with 5+ years leading teams.
Strong technical expertise in cGMPs, quality audits, statistics, testing, and manufacturing operations.
ASQ CQE or CMQ/OE preferred.
Responsibilities
Manages a team responsible for QI for received contract manufactured product.
Oversees team responsible for inspecting ingredients and components received, and finished goods.
Skills
FDA-regulated consumer products experience
Leadership
cGMP knowledge
Quality audits
Statistics
Manufacturing operations
Education
Bachelor’s degree in engineering or science
Master’s in Engineering
Tools
Agile PLM
LIMS
Warehouse management/JDE
Job description
Qualifications and Responsibilities
7+ years of experience in FDA‑regulated consumer products, with 5+ years leading teams.
Bachelor’s degree in engineering or a science discipline (Master’s in Engineering preferred).
Heavy system compliance, ops and production based, pharma mfg. exp. is good, identifies what is and is not quality, QMS and systems knowledge (Agile PLM, LIMS and Warehouse management/JDE).
Manages directly the team (2 people) which is responsible for QI for received contract manufactured product.
Oversees Group Leader whose team (15 people) is responsible for inspecting ingredients and components received, and finished goods being manufactured.
Strong technical expertise in cGMPs, quality audits, statistics, testing, and manufacturing operations; ASQ CQE or CMQ/OE preferred.