Potency QC Analyst (HPLC, GMP) - Contract

System One, Inc.; Rockville (MD); In loco; USD 65.000 - 90.000; Part-time

Vantaggi offerti da questo lavoro

Health benefits

Dental

Vision

401(k) plan

Life insurance

Descrizione del lavoro

System One is seeking a QC Analyst - Potency in Rockville, MD to join a biopharmaceutical team on a contract basis. The role focuses on potency testing, GMP-compliant documentation, and instrument-assisted analysis to ensure product quality.

The ideal candidate holds a Bachelor’s degree in a related scientific field and has hands-on experience with HPLC and GMP environments, with strong collaboration skills for cross-functional teams in quality assurance and manufacturing.

Competenze

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or related scientific field.
• Experience as a QC analyst in pharmaceutical/biotech settings preferred.
• Proficiency with laboratory instrumentation, especially HPLC.
• Strong documentation and attention to detail.
• Knowledge of GMP regulations and lab safety protocols.
• Effective communication and teamwork in a regulated environment.

Mansioni

• Perform testing and analysis of potency samples per established protocols and GMP.
• Ensure accurate documentation of test results and maintain records for audits.
• Operate lab instruments like HPLC and spectrophotometers to assess sample quality.
• Interpret data, prepare reports, and communicate findings to cross-functional teams.
• Maintain a clean, compliant lab environment following safety standards.
• Collaborate with QA and manufacturing to support product release and stability studies.

Conoscenze

Attention to detail

Documentation

Team collaboration

GMP knowledge

Formazione

Bachelor’s degree in Chemistry, Biology, Biochemistry, or related field

Strumenti

HPLC

Spectrophotometers

Descrizione del lavoro

Job Title: QC Analyst - Potency
Location: Rockville, MD
Type: Contract
Schedule: Monday - Friday 8am-5pm

Overview
Biopharmaceutical Company is seeking a QC Analyst to join their team in Rockville, MD!

Responsibilities

• Perform testing and analysis of potency samples in accordance with established protocols and Good Manufacturing Practices (GMP).
• Ensure accurate documentation of test results and maintain thorough records for compliance and audit purposes.
• Operate laboratory instrumentation such as HPLC, spectrophotometers, and other analytical tools to assess sample quality.
• Interpret data, prepare reports, and communicate findings to cross-functional teams.
• Maintain a clean, organized, and compliant lab environment, adhering to safety standards and company policies.
• Collaborate with quality assurance and manufacturing teams to support product release and stability studies.

Requirements

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field.
• 4-5 years of experience in GMP environment performing ELISA's, MSD, and bioassays for potency residuals within a biotech company.
• Experience with good documentation practices required. (may consider CLIA or GLP experience if candidates do not have GMP)

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific