Benefits:
401(k)
Competitive salary
Dental insurance
Health insurance
Opportunity for advancement
Paid time off
Vision insurance
POSITION PURPOSE
The Quality Manager is responsible for developing, improving, and implementing cGMP standards at Bayport Laboratories to ensure compliance with federal, state regulations, and customer requirements. Responsible for implementing training programs that support continuous improvement.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
• Ensure compliance with federal, state regulations, and customer specifications related to the quality of the products • Execute and manage closure of quality systems related records such as Deviations, CAPAs, NCMR, Complaints, and Recalls • Color matching and innovation • Execute and manage review and approval of quality operation documents such as batch records, Quality Control Data • Execute and manage implementation of quality systems and processes • Support implementation of cGMP • Support customer and regulatory audit preparation, facilitation, and follow up • Execute Internal Audit Program • Responsible for disposition of raw materials, components, WIP, bulk, and finish goods • Reviews equipment calibration records to ensure that are performed as indicated in the Bayport Laboratories Standard Operating Procedure • Assist on manufacturing processes as needed • Participate in team meetings • Conducts risk assessment and implement corrective actions • Utilize Hands on approach in performing all functions • Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends • Work with purchasing to ensure approved supplier use • Implement and performs training • Educate employees on preventing work related health problems and perform EHS training • Ensure compliance with EHS procedures • Responsible for identifying and remediating hazardous workplace conditions
PERFORMANCE MEASUREMENTS
Yearly reviews to asses success and determine areas of improvement
QUALIFICATIONS
EDUCATION/CERTIFICATION: • BS or MS degree in Chemistry, Biology, Cosmetic Science
REQUIRED KNOWLEDGE: • Familiarity with regulatory standards including cGMP, FDA, and ISO 22716 (2007)
EXPERIENCE REQUIRED: • Proficiency in developing and delivering GMP training • A minimum of 5 years of experience in Pharmaceutical, Medical Device, Cosmetic manufacturing
SKILLS/ABILITIES: • Excellent communication skills • Detailed oriented with strong analytical and problem-solving skills • Experience in Quality Systems