A pharmaceutical company located in Indianapolis is seeking an Associate in Quality Assurance. This role involves performing aseptic testing, conducting biological evaluations of products, and supporting laboratory investigations. The ideal candidate has a Bachelor's degree in Biology or Microbiology and 2-4 years of experience in a cGMP-compliant setting. This is a full-time position offering a competitive salary between $55,000 and $65,000 yearly.
Qualifications
2-4 years of experience in a related field, ideally within a cGMP-compliant setting.
Experience in microbiological testing to support product quality and efficacy.
Proficient in computer usage and data entry systems.
Responsibilities
Perform aseptic testing on drug products and materials according to SOPs.
Conduct in vivo biological testing to evaluate effectiveness of products.
Monitor microbial growth, isolate cultures, and manage data.
Skills
Analytical abilities
Problem-solving
Communication
Attention to detail
Teamwork
Education
Bachelor's degree in Biology, Microbiology or related fields
Job description
Base pay range
$55,000.00/yr - $65,000.00/yr
Direct message the job poster from Harba Solutions Inc.
Responsibilities
Perform aseptic testing (Sterility, Endotoxin, Particulates, Bioburden) on drug products and materials in accordance with SOPs and regulatory guidelines.
Conduct in vivo biological testing to evaluate the effectiveness and quality of products.
Carry out Growth Promotion testing on microbiological media based on established methods.
Prepare and assess Biological Indicators for Validation and Qualification procedures.
Monitor microbial growth, isolate cultures, and manage data within Laboratory Management Systems (LIMS).
Work closely with team members to ensure efficient and timely completion of testing and related tasks.
Support laboratory investigations, including root cause analysis and corrective action implementation.
Qualifications
Bachelor's degree in Biology, Microbiology or related fields.
2-4 years of experience in a related field, ideally within a cGMP-compliant setting.
Experience in microbiological testing to support product quality and efficacy.
Strong analytical, problem-solving, and communication abilities.
High attention to detail with the ability to work independently or as part of a team.
Proficient in computer usage and data entry systems.
Consistent attendance and a flexible, team-oriented mindset.
Seniority level
Associate
Employment type
Full-time
Job function
Research, Quality Assurance, and Product Management
Industries
Pharmaceutical Manufacturing and Biotechnology Research