Quality Assurance & Quality Control, Quality/Risk Management, Regulatory Compliance, Research & Development
The Bionetics Corporation is seeking an RQAP-GLP certified Quality Assurance Manager to support the activities of the animal care contract located at the FDA/HHS - National Center for Toxicological Research (NCTR), Division of Veterinary Services, Jefferson, Arkansas.
The Bionetics Corporation is a government services contractor specializing in engineering and life sciences with locations nationwide. This location features a very reasonable cost of living and a wide variety of outdoor activities such as hunting, fishing, boating, etc.
The Quality Assurance Manager is responsible for developing, implementing and oversight of the Quality Program. This position will conduct inspections of a variety of processes to assure compliance with applicable regulatory requirements, standards, corporate policies and procedures in the FDA animal research facility in Jefferson, Arkansas.
Responsible for oversight of Quality Control and Assurance services provided to the Food and Drug Administration at NCTR.
Performs audits of technical programs within the facility ensuring all activities in the facility are held at the same level of compliance.
Ensure the activities supporting GLP protocols are compliant with 21 CFR Part 58 (GLPs), 40 CFR Parts 160 and 792.
Prepare audit schedules.
Record and compile audit data as required.
Identify and assess problem areas and work with the appropriate personnel to address any issues.
Lifting/Moving Requirements – Minimum of 50 pounds
Work is performed mainly indoors in a laboratory environment and/or in an animal care, barrier facility, surgical or test procedure facility, diet/water prep facility, or animal housing/bedding cleaning and prep areas. Work may require use of personal protective equipment (PPE) in both areas. Work area may be prone to hot and humid conditions, and subject to objectionable odors, aerosols, dust, animal dander, and noise.
EQUAL OPPORTUNITY EMPLOYER:
VEVRAA Federal Contractor
Employability in the U.S. and pre-employment drug screen required.
Bionetics offers a competitive salary and benefits package to include medical, dental and vision insurance, 401k with company matching, paid holidays, paid vacation and sick leave, life insurance, etc.
Qualified candidates should submit their resume to:
Fax: (757) 952-3700 Attn: S. Hayes
Must have a High School Diploma or equivalent. Bachelor’s Degree in Regulatory Science preferred.
Three (3) - Five (5) years’ experience in regulatory management and administration.
Previous experience in a GLP or GMP environment is highly desirable.
Shall have Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP) certification.
Possess the knowledge and skills to develop and standardize a quality program for activities within the facility.
Possess excellent organizational and communication skills.
Should have knowledge of laboratory animal technician duties and training.
Must possess excellent knowledge of Federal, State, and local regulations governing Animal Care/Diet Preparation facilities.
Good knowledge of both spoken and written English.
Must be a legal resident of the United States.
Employer will assist with relocation costs.
Internal Number: 1
About The Bionetics Corporation
The Bionetics Corporation is a diversified engineering and applied science company with a strong heritage of exceptional customer service to federal, state, local and commercial markets. Bionetics was formed in 1969 by five scientists to support the Viking mission to Mars, and our service to the aerospace and scientific community continues to this day. With annual sales in excess of $45 million, and over 300 employees, Bionetics can access the full range of skills and capabilities to address customer challenges.
We work in partnership with our clients to develop a shared Vision of the future. We solve problems and deliver business results that add Value. Finally, we create and maintain an environment of Integrity and trust throughout our business operations.