QC Analyst

Scientific Protein Laboratories LLC; United States; On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical on Day 1

Dental on Day 1

Vision on Day 1

Life Insurance

AD&D Insurance

Short and Long-term Disability

Health Savings Account options

Employee Assistance Program

Generous vacation

Paid Holidays

401k

Advancement opportunities

Team-oriented environment

Community involvement

Company events

Job summary

Scientific Protein Laboratories LLC (SPL) is a world leader in biosourced pharmaceuticals located just outside Madison, Wisconsin in Waunakee. The Up to Sr QC Analyst – Molecular Technologies role focuses on complex routine laboratory analyses of APIs under cGMP/FDA guidelines, including PCR-based methods, data interpretation, and mentoring other analysts.

Qualified candidates typically hold a high school diploma or GED with a Bachelor's in biochemistry or related discipline; 5+ years in

Qualifications

• 5+ years of molecular technology experience; 10+ years preferred.
• Experience performing PCR-based analyses and analytical method development.
• Follows cGMP/FDA guidelines and documents results accurately.

Responsibilities

• Perform scheduled testing of raw materials, in-process, finished products and APIs.
• Execute PCR-based sample prep, DNA/RNA extraction and Master Mix preparation.
• Record data in documents and electronic files; communicate issues to management.
• Lead experiments, validate instruments, and interpret results with minimal supervision.
• Train analysts in lab processes, assays, and systems as required.
• Investigate OOS data, write investigation summaries, and coordinate calibration.
• Review SOPs and act as a technical resource for compliance; review peers' work.

Education

High School Diploma or GED

Bachelor's in Biochemistry or related field

Job description

JOB SUMMARY

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an Up to Sr QC Analyst – Molecular Technologies.

Responsible for performing complex routine 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. Initiates and executes independent analytical and systems improvement projects.

Responsibilities include :

• Perform the scheduled laboratory testing of raw material, in-process, finished product APIs and special products.
• Perform PCR-based techniques such as sample homogenization, extraction of DNA/RNA, and preparation of Master Mixes for PCR reactions
• Properly record all data results on appropriate documents and in electronic files, including immediate communication of issues to management, both in own work and others in the lab.
• With minimal assistance from management, author, execute and interpret laboratory experiments, analytical method and instrument validation efforts as necessary.
• Train other analysts in overall laboratory processes/systems and in general and complex assays, as required.
• Oversee, interpret results and perform analytical investigations for OOS (Out-of-Specification) and atypical data. Assist in the gathering of evidence or results. Write summary reports detailing the investigation.
• In areas of ownership, coordinate with vendors and other analysts to perform routine calibration and preventive maintenance of laboratory equipment.
• Review/Revise SOPs and serve as a technical resource to ensure compliance with compendial documents.
• Review and interpret the work of other analysts.

Job Requirements and Qualifications :

• Education: High School Diploma or G.E.D.; Bachelor’s degree or above in biochemistry or related discipline preferred.
• Experience: 5+ years of experience required, 10+ years of experience preferred. Molecular technology development experience is highly desirable.

WHY JOIN SPL?

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.