What are the responsibilities and job description for the QC Analyst (Biotech) position at Piper Companies?
Piper Companies is seeking a QC Analyst to perform routine quality control testing to support GMP manufacturing operations, with a focus on environmental monitoring, bioburden, endotoxin, and TOC testing out of Durham, NC.
Responsibilities of the QC Analyst:
Keywords:
Microbiology, Microbiologist, Endotoxin, Environmental Monitoring, EM, Bioburden, LAL, TOC, non-viable, surface testing, surface sampling, TOC analysis, MODA, LIMS, biotech, pharmaceutical, manufacturing, drug product, cleanroom, water systems, in-process sample, raw materials, validation, media, buffer, reagent, personnel monitoring, analytical, microbiological, microbial, total organic carbon, cGMP, current good manufacturing practice, good manufacturing practice, GLP, controlled environment, routine testing, QC, Quality Control, QC Analyst, QC Microbiologist, Environmental Monitoring Technician, Microbiology Associate, FDA, EMA, USP, ISO, SOP, Standard Operating Procedure, Durham, QMS, Bioprocess, Biomanufacturing, Commercial Operations, Environmental Testing, Environmental, Environmental Sampling
Responsibilities of the QC Analyst:
- Perform environmental monitoring (viable/non‑viable air, surface, and personnel sampling)
- Conduct bioburden testing, endotoxin testing (LAL), and TOC analysis
- Document and review test results in compliance with cGMP requirements
- Trend data and support investigations, deviations, and CAPAs
- Maintain laboratory equipment and support qualification/validation activities
- Follow SOPs and support audits and inspections as needed
- 1-3 years of working in microbiology in a GMP environment
- Hands‑on experience with environmental monitoring, bioburden/endotoxin, and TOC testing
- Working knowledge of cGMP and basic microbiology techniques
- Experience with water systems, viable, non-viable, surface sampling
- Bachelor’s degree in science related field
- Salary: $50,000 - $70,000 *commensurate with experience*
- Comprehensive Benefits: Medical, Dental, Vision 401k, Paid Holidays, PTO (Paid Time Off), Sick leave required as by law
Keywords:
Microbiology, Microbiologist, Endotoxin, Environmental Monitoring, EM, Bioburden, LAL, TOC, non-viable, surface testing, surface sampling, TOC analysis, MODA, LIMS, biotech, pharmaceutical, manufacturing, drug product, cleanroom, water systems, in-process sample, raw materials, validation, media, buffer, reagent, personnel monitoring, analytical, microbiological, microbial, total organic carbon, cGMP, current good manufacturing practice, good manufacturing practice, GLP, controlled environment, routine testing, QC, Quality Control, QC Analyst, QC Microbiologist, Environmental Monitoring Technician, Microbiology Associate, FDA, EMA, USP, ISO, SOP, Standard Operating Procedure, Durham, QMS, Bioprocess, Biomanufacturing, Commercial Operations, Environmental Testing, Environmental, Environmental Sampling
Salary : $50,000 - $70,000