QC Lab Analyst 2nd Shift (423)

Society for Conservation Biology; Virginia (MN); On-site; USD 55,000 - 85,000; Full time

Job summary

An established industry player is seeking a QC Lab Analyst for their Petersburg, Virginia site. This role involves supporting the manufacture of essential sterile injectable medications through analytical testing and method validations. You will ensure compliance with regulatory standards and contribute to a culture of safety and continuous improvement. If you are a self-motivated individual with a strong background in laboratory practices and a passion for improving patient care, this opportunity is perfect for you. Join a mission-driven organization dedicated to eliminating drug shortages and stabilizing prices.

Qualifications

• 4+ years of regulated lab experience in a scientific discipline.
• Knowledge of FDA, ICH, and USP guidelines.

Responsibilities

• Perform analytical testing and maintain equipment for sterile injectable medications.
• Lead laboratory investigations and ensure compliance with regulatory standards.

Skills

Analytical Testing

HPLC Analysis

LIMS Proficiency

Method Validation

Regulatory Compliance

Multitasking

Education

Bachelor's Degree in a Scientific Discipline

Tools

Empower Software

MS Office

Job description

View more categories View less categories Sector Consultancy/Private Sector Field Conservation science Discipline Biology Salary Type Salary Employment Type Full time

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare, with over 300 medications currently in shortage, impacting patient safety and hospital resources.

Civica, founded in 2018 by health systems and philanthropies, is a nonprofit organization dedicated to preventing and mitigating drug shortages. It serves nearly 60 health systems across 49 states, supplying essential medicines to government agencies and hospitals.

Civica's mission extends to CivicaScript, which aims to make outpatient generic medicines affordable and available through partnerships with manufacturers, payors, and pharmacies. The organization is also building a state-of-the-art manufacturing facility in Virginia to produce sterile injectables and biosimilar insulins, ensuring access and affordability.

The Civica Foundation supports philanthropic efforts, notably in providing affordable insulin to Americans, collaborating with stakeholders across the diabetes ecosystem.

Join us in leading a movement for patients, not profits, to eliminate shortages and stabilize prices. Learn more at www.civicarx.org

Job Description:

The QC Lab Analyst 2nd Shift will join Civica at the Petersburg, Virginia site, supporting the manufacture of essential sterile injectable medications. Responsibilities include performing analytical testing, maintaining equipment, and executing method verifications and validations, ensuring compliance with regulatory standards such as cGMP and FDA guidance.

Essential Duties and Responsibilities:

• This position is on the second shift; training occurs on the first shift initially.
• Perform analytical testing, interpret, and document results accurately.
• Participate in method transfers, verifications, and validations.
• Report OOS, OOT, or atypical results promptly.
• Lead or assist in laboratory investigations.
• Perform HPLC analysis with minimal supervision; experience with Empower software is a plus.
• Maintain LIMS data integrity.
• Promote safety and maintain a clean, organized workspace following 6S principles.
• Contribute to continuous improvement initiatives.
• Work effectively independently and as part of a team.
• Manage chemical inventory and supply ordering.
• Perform additional duties as assigned.

Basic Qualifications and Capabilities:

• Bachelor's degree in a scientific discipline with 4+ years of regulated lab experience.
• Proficiency with LIMS, analytical data software, and MS Office.
• Ability to multitask in a fast-paced environment.
• Self-motivated with a willingness to learn.
• Knowledge of FDA, ICH, and USP guidelines; experience with wet chemistry, pH, conductivity, atomic absorption, and loss on drying; proficient in HPLC analysis.
• Experience in preparing and reviewing technical documents, and in method transfers, verifications, validations.

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