Quality Assurance Manager (Animal Care)
The Quality Manager will develop and implement the quality assurance program for the FDA animal research facility in Jefferson, Arkansas. This position is responsible for performing facility, process, vendor and local validation audits to assure compliance with the Good Laboratory Practice Regulations (GLP) and laboratory Standard Operating Procedures. The Animal Laboratory Technologist uses a broad range of records, reports and conducts inspections of a variety of processes to assure compliance with applicable regulatory requirements, standards, corporate policies and procedures.
1. Must have a High School Diploma or equivalent and 3-5 years’ experience in regulatory management and administration in a GLP or GMP environment is highly desirable. Bachelor’s degree in Regulatory Science preferred.
2. Must have Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP) certification.
3. Possess the knowledge and skills to develop and standardize a quality program for activities within the facility.
4. Possess excellent organizational and communication skills.
5. Must have knowledge of laboratory animal technician duties and training.
6. Must possess excellent knowledge of Federal, State, and local regulations governing Animal Care/Diet Preparation facilities.
7. Good knowledge of both spoken and written English.
8. Must be a legal resident of the United States.
• Responsible for oversight of Quality Control and Assurance services provided to the Food and Drug Administration, performing audit 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.
• Identifies and assess problem areas and work with the appropriate personnel to address any issues.
• Perform other related duties as assigned.
• Occasionally – Climbing, Stooping, Kneeling
• Often – Reaching, Standing, Sitting, Walking, Pushing, Pulling, Talking, Hearing, Seeing
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.
Candidates should submit their resumes to:
Address: The Bionetics Corporation, 101 Production Drive, Ste. 100, Yorktown, VA 23693, Attn: S. Hayes
EQUAL OPPORTUNITY EMPLOYER: Minority/Female/Disabled/Veteran
VEVRAA Federal Contractor
Employability in the U.S. and pre-employment drug screen required.