PCR Analyst 2nd and 3rd shift

at Scientific Protein Laboratories
Location Waunakee, Wisconsin
Date Posted July 9, 2021
Category Bioscience
Job Type Full-time
Address PO Box 158

Description

Scientific Protein Laboratories LLC (SPL) is a manufacturer of Active Pharmaceutical Ingredients (APIs) in the greater Madison, Wisconsin area.  Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation. We are seeking two Analysts to join the Microbiology/PCR team in the Quality Control department. The roles require precision, dedication, and teamwork.

3rd shift Associate QC Analyst
•Shift: Monday, Tuesday, Wednesday, Thursday (approximately 9PM to 7:30AM) and additional hours as needed

2nd shift QC Analyst
•Shift: Monday, Tuesday, Wednesday, Thursday (approximately 12PM to 10:30PM) and additional hours as needed


Analysts are responsible for performing laboratory analyses on APIs following strict written procedures derived from the United States Pharmacopoeia and/or other documents, to meet strict compendial and custom specifications. This work is performed under the cGMP/FDA guidelines. Additional responsibilities include participating in analytical and systems-improvement projects.

Responsibilities

• Follow Standard Operating Procedures (SOPs) to obtain accurate results.
• Perform the scheduled laboratory testing of raw material, in-process, finished product APIs and special products.
• Properly record all data results on appropriate documents and in electronic files, including immediate communication to management of all issues.
• In a timely manner, prepare reagents, verify the documentation of those reagents and report if inventory levels of quality stock reagents need to be maintained.
• Perform routine calibration and preventive maintenance of laboratory equipment.
• Ensure that the work area is maintained in a clean condition and free from clutter.
• May assist in laboratory experiments, analytical and instrument validation procedures as necessary.

More experienced Analysts are responsible for:

• Authoring and/or executing laboratory experiments, analytical method and instrument validation efforts as necessary with assistance from management.
• Reviewing/Revising SOPs to ensure compliance with compendial documents.
• Reviewing and interpreting the work of other analysts.

Qualifications
  • Bachelor's degree in Biology, Biotechnology, Microbiology, or related field
  • Associate QC Analyst level – 2+ years of PCR experience preferred.
  • QC Analyst level – 5+ years of PCR experience preferred.
  • Experience with qPCR method development and optimization, as well as writing protocols, SOPs and methods. This includes driving process, designing primers and probes; troubleshooting; instrumentation
  • Excellent oral and written communication skills
  • Solid understanding of cGMP, GLP or other relevant regulations
  • Embrace, and exhibit behaviors consistent with, SPL’s company-wide competencies: Accountability, Communication & Teamwork, Innovation & Creativity, Technical Mastery, and Customer-Focus

 

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