Quality Control Analyst II

About the Role

USDM Life Sciences is seeking a QC Analyst to support various activities within the QC department, including executing analytical method transfers, conducting biological, chemical, and physical analyses, and supporting investigations of nonconformances. This role is crucial in ensuring the quality and compliance of raw materials, in-process samples, and final products in a cGMP environment.

Responsibilities

• Conduct biological, chemical, and physical analyses on samples, including raw materials, in-process, and final products, as well as environmental monitoring samples, according to SOPs and protocols.
• Drive the implementation of new methodologies or sample types into existing methods in the QC laboratory.
• Support investigations of nonconformances and troubleshoot unexpected results.
• Manage multiple tasks, including testing and inventory management, in a timely and appropriate manner.
• Perform review of test data, including documentation practices (CGDP).
• Support the generation and documentation of validation protocol deliverables.
• Draft and update QC SOPs as required.
• Perform test equipment maintenance and calibrations.

Qualifications

• General understanding of laboratory functions, test methods, equipment (e.g., HPLCs, plate readers), and procedures.
• Knowledge of laboratory safety, including standard precautions and handling of hazardous and biohazardous chemicals.
• Familiarity with wet and instrumental methods of analyses.
• Ability to operate and troubleshoot lab equipment.
• Preferred: General knowledge of FDA regulations, GLP, GMP, and GDP.
• Preferred: Knowledge of quality and regulatory requirements in pharmaceutical manufacturing labs.
• Preferred: Experience in writing detailed investigation reports and applying root cause failure analysis.

Education & Certifications

• High School degree or equivalent required; Bachelor’s Degree in Chemistry, Microbiology, or Biological Sciences strongly preferred.
• Minimum 2 years of related work experience.
• Preferred: Experience in quality operations, biotechnology, pharmaceutical, or similar GMP manufacturing environment.

Working Conditions

The role involves prolonged periods of sitting or standing at a desk, working on a computer in a home office environment, and operating office machinery. Frequent communication with stakeholders via telephone, email, or instant message is required. Reasonable accommodations may be made for individuals with disabilities.

Pay

Salary/Hourly Rate Range (W2): USD 40.00 - 60.00. Actual compensation will vary based on qualifications, skills, and proficiency for the role.

Benefits

• Health, vision, and dental insurance for full-time employees.
• Life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage for full-time employees.
• 401k plan eligibility for employees aged 21 and above.
• Paid time off for eligible full and part-time employees.
• Rewards and recognition program for all employees.