What are the responsibilities and job description for the QC Operations Specialist II (Durham, NC) position at Piper Companies?
Piper Companies is searching for a highly skilled and motivated QC Operations Specialist II to join the Quality Control team of a biotechnology company dedicated to advancing biopharmaceutical development and manufacturing. The QC Operations Specialist II is responsible for leading contract testing laboratory activities, cross-functional communications, implementation of control charts, and compilation of testing for batch release. The successful candidate will also author certificates and laboratory investigations in the contract manufacturing facility, which produces monoclonal antibodies, recombinant proteins, and peptides.
This is a first shift on-site position, Monday through Friday, in Durham, NC.
Responsibilities of the QC Operations Specialist II:
Keywords: QC, QC Operations, Deviation, Investigation, Biologic, Biologic Production, Biotechnology, Quality Control, Good Manufacturing Practices, GMP, Standard Operating Procedures, SOP, Analytical Testing, Environmental Monitoring, Microbiology, Bioburden Testing, Endotoxin Testing, Data Analysis, Laboratory Equipment Maintenance, Compliance, Regulatory Standards, Quality Assurance, QA, Validation, Documentation, Troubleshooting, Aseptic Techniques, Chromatography, HPLC, GC, Spectroscopy, UV/Vis, IR, Laboratory Information Management System, LIMS, Durham, RTP, Raleigh, North Carolina
LI-PB2
This is a first shift on-site position, Monday through Friday, in Durham, NC.
Responsibilities of the QC Operations Specialist II:
- Manage contract testing laboratory activities, ensuring proper delivery of samples and timely results
- Author data summaries, certificates, and laboratory investigations
- Lead and review lab investigations and deviation reports
- Assist in CAPA implementation and resolution
- Participate in inspection readiness activities
- B.S. degree with 6 years of related experience, M.S. degree with 4 years of related experience, or Ph.D. with 1 years of relevant experience in a related scientific discipline
- Strong biochemistry background in biopharmaceutical analytical testing and a strong understanding of the biologics production process
- Proficient in writing technical documents and presenting complex data
- Experience with HPLC, ELISA, qPCR, SoloVPE, and other analytical techniques
- Salary Range: $40/hr - $55/hr based on experience
- Comprehensive Benefits including Medical, Dental, Vision, 401k, PTO, Sick Leave if required by law, & Holidays
Keywords: QC, QC Operations, Deviation, Investigation, Biologic, Biologic Production, Biotechnology, Quality Control, Good Manufacturing Practices, GMP, Standard Operating Procedures, SOP, Analytical Testing, Environmental Monitoring, Microbiology, Bioburden Testing, Endotoxin Testing, Data Analysis, Laboratory Equipment Maintenance, Compliance, Regulatory Standards, Quality Assurance, QA, Validation, Documentation, Troubleshooting, Aseptic Techniques, Chromatography, HPLC, GC, Spectroscopy, UV/Vis, IR, Laboratory Information Management System, LIMS, Durham, RTP, Raleigh, North Carolina
LI-PB2
Salary : $40 - $55
