Quality Control Analyst

The Fountain Group; Lexington (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company is seeking a Quality Control Analyst for a fully onsite role in Lexington, MA. The position involves lab operations, testing for pharmaceutical and biotechnology products, and ensuring compliance with quality standards. Candidates should have a bachelor's or master's degree with relevant experience, and hands-on skills with various assays.

Qualifications

• 2-5 years of experience in the pharmaceutical or biotechnology industry in a Quality Control setting.
• Familiarity with ELISA, bioassays, SDS-PAGE Silver, qPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, and A280.

Responsibilities

• Focus on daily lab operations and execution of testing to support manufacturing operations.
• Maintain operational and GMP readiness of the QC areas.
• Participate in testing execution and QC operations support.

Skills

Hands-on skills with assays

Education

Bachelors or master’s degree

Job description

Job Title: Quality Control Analyst
Location:Fully onsite in Lexington, MA
Pay: $40-58 hourly, depending on experience level
Hours: Flexible, M-F, 9am-5pm (40 hours per week)
Contract: 12-month contract, potential for extension/conversion

Job Description:

• Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.
• Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols.
• May assist in sampling activities.
• This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities.
• In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.
• Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., to support in-process, release, and stability testing.
• Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation.
• 40-50% Testing execution, participate in training analysts, trouble shooting of methods.
• 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records).
• 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support.

Qualifications:

• Bachelors or master’s graduates with 2-5 years of experience in the pharmaceutical or biotechnology industry in a Quality Control (QC) setting.
• Hands on skills with one or more of the following assays: ELISA, bioassays, SDS-PAGE Silver, qPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, and A280.