Job Description

Quality Control Analyst I, EM

Location: Vacaville, CA (Onsite)

Reports to: QC Manager, EM

Job Type: Full-time

FLSA: Non- Exempt

Company Overview

Polaris Pharmaceuticals, part of Polaris Group, is a multinational biotechnology company focused on the discovery, development, and manufacturing of innovative therapies, with a primary focus on oncology. The company’s lead therapeutic candidate, pegargiminase (ADI-PEG 20), is currently in late-stage clinical development across multiple cancer indications.

Polaris operates across the full drug development lifecycle, from research and clinical development to cGMP manufacturing. With facilities in the United States and Asia, the company combines scientific innovation with integrated development and manufacturing capabilities to advance therapies for patients worldwide.

Job Summary

The Quality Control Analyst I, EM ,under direct or minimal supervision, is responsible for environmental monitoring as well as performing analytical analysis of samples compliant with cGMP guidelines. The Analyst works independently on assays that they have mastered. This position requires willingness to undergo training on more advanced analytical methods and always employs laboratory safety policies. The Analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime as required.

Key Responsibilities

• Perform routine environmental and utility sampling and testing of cGMP areas.
• In addition to environmental monitoring, performs analytical analyses of utility test samples under cGMP to meet specified timelines.
• Evaluates data against defined criteria/specifications.
• Identify and support OOS/OOE/OOT investigations.
• Maintains the laboratory in an inspection-ready state.
• Performs routine laboratory functions/chores for the QC laboratory.
• Develops and maintains proficiency in trained test methods.
• Holds self and others responsible to abide by department and company policies and practices.
• Develops familiarity concerning cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements as required.
• Manage reagent and equipment inventory for assigned areas of responsibilities.

Required Qualifications

• Perform tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Works independently as well as in a team environment.
• Familiarity with use of a computer: e. g., Proficient in Windows, Microsoft Word, Excel.
• Good written and verbal communication skills.
• Strong documentation skills a must.
• The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers.

Preferred Qualifications

• B. S./B. A. in Science/Related Field (major in microbiology, biology-biochemistry-chemistry).
• 0-3 years of relevant laboratory experience is desired
• Experience with GMP and environmental monitoring and analysis.
• Specific tests include TOC, Endotoxin, Bioburden, and Conductivity.

Physical / Work Environment

• Ability to work in a cleanroom environment and qualify for aseptic gowning.
• Ability to stand for extended periods and perform repetitive tasks.
• Ability to lift approximately 25–40 lbs.
• Work in a cGMP regulated manufacturing facility
• Ability to wear required PPE including gowning, gloves, and masks
• Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

Salary Range

• $30-$35 per hour

Benefits

Polaris Pharmaceuticals offers a comprehensive benefits package, which may include:

• Medical, dental, and vision insurance
• 401(k) retirement plan
• Paid time off and company holidays

Equal Employment Opportunity Statement

Polaris Pharmaceuticals is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local laws.

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