Job Posting:QA Compliance Associate II
The Senior QA Compliance Associate is a key member of the Quality Assurance group and utilizes an extensive background in Quality Systems to review product related procedures and records in order to ensure that the final product meets GMP and company (and customer) standards.
Major Position Activities & Responsibilities
- Fully cross trained and responsible for reviews of all types of documentation reviewed / approved by QA Product Release group, including raw materials, all types of in process and finished batch records, laboratory and environmental results, shipping documentation, temperature data reviews and LIRs/NC/Deviations
- Ensures that all documents reviewed are in accordance with GMP and company requirements
- Acts as a subject matter expert for other QA Compliance Associates, QA Inspectors, and individuals outside of the department
- Participates as QA representative in interdepartmental teams and projects, as assigned
- Trains new departmental employees
- Maintains and presents QA-PR data and reports on applicable departmental metrics
- Provides needed QA information in answer to customer requests and for annual product quality reviews
- Provides suggestions for improvements in QA procedures and processes
- Performs special projects and other duties as assigned
- As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
The Compliance Associate has no supervisory responsibilities. The associate is expected to maintain expenses within budget constraints and to perform within expected departmental goals and metrics.
- Position requires Bachelor’s degree in biology, chemistry, pharmacy or related scientific discipline
- Two or more years’ experience in Quality Assurance and three years in pharmaceutical or medical device industry experience required, in a technical or Quality role.
- Experience with sterile drug products and biopharmaceuticals preferred; knowledge of Indianapolis site products and production processes is a plus
- Must be detail oriented, able to juggle multiple duties simultaneously; team focused, have strong planning/organization skills, high stress tolerance; and be results driven.
- Must have proven ability and skill in analyzing, understanding, and reviewing technical data
- Requires the ability to perform occasional, unscheduled overtime.
- Working knowledge of Quality Auditing principles.
- Ability to write reports, correspondence, and SOPs
- Familiarity with computer use including Microsoft Excel, Word and Access
- Excellent interpersonal and problem-solving skills
- Familiar with SAP and QTS