Quality Control Associate

Quality Control Associate

Natick, MA • Full Time

Job Description
Provides general support to maintain quality control systems within the company. Ensures that performance and products conform to all GMP standards.

Responsibilities

Analyzes chemical, biological, or microbiological products, raw materials, in process materials in support of the company’s Quality, Manufacturing, and Regulatory program. Performs environmental monitoring in cleanroom suites and qualitative tests or quantitative assays as needed. Interprets and evaluates results, identifies out of specification test results, interprets, analyses, and recommends corrective action where necessary. Review data obtained for compliance to specifications and report abnormalities. Compile data for documentation of test procedures, review, and approval and archival of documentation as required. Calibrate and maintain lab equipment according to calibration program.

Basic laboratory and cleanroom housekeeping and maintenance of supplies. May order materials for these locations. Participate in the preparation of investigations, summaries, and reports. May assist in developing testing methods. Revise and update standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. Applies knowledge of GMP, GLP and GRP daily. Follows written test methods and protocols.

Required Skills
GMP, Microbiology, Quality Control

Required Qualifications
BS Degree in a scientific discipline. Formal GMP training. At least 1 year experience in a GMP pharmaceutical setting, and at least 1 year experience in quality control. Preferably cell therapy products experience. Good interpersonal skills, Microsoft Excel, Word, and Power Point skills preferred.

Experience Level

Intermediate Level

To apply, please submit your cover letter/ resume to: schang@hebecell.com