Quality Control PChem Analyst I or II

CLENE NANOMEDICINE INC • North East, MD

6h • $25 - $28

About The Position

Clene is hiring a Quality Control P-Chem Analyst at the Analyst I or II level to perform analytical testing on bioanalytical and production samples from contract research organizations, manufacturing operations, and Research & Development. The role supports the quality, safety, integrity, and compliance of products and is conducted in accordance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), Standard Operating Procedures (SOPs), validated test methods, and established laboratory procedures.

The Analyst I level is suited to an early-career laboratory professional developing technical skills under appropriate supervision. The Analyst II level is suited to an experienced professional able to test with greater independence, apply technical judgment, and contribute to investigations and quality activities. Level is based on education, laboratory experience, technical skills, and demonstrated independence.

This is a full-time position with a consistent weekday schedule; specific hours may vary with business needs. Compensation is $25.00–$28.00 per hour, based on qualifications and experience. Clene offers opportunities to build technical expertise and grow within Quality Control and pharmaceutical manufacturing.

Requirements

• Working knowledge of cGMP and cGLP requirements.
• Strong analytical, critical-thinking, and problem-solving skills.
• Experience operating and troubleshooting laboratory instrumentation.
• Commitment to accuracy, attention to detail, and data integrity.
• Ability to recognize and communicate laboratory, analytical, equipment, and quality issues.
• Ability to read, interpret, and follow technical documents, SOPs, test methods, protocols, and laboratory procedures.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications.
• Ability to work independently and collaborate effectively with a cross-functional team.
• Strong organizational skills and ability to manage multiple priorities.
• Commitment to laboratory safety, quality, compliance, and continuous improvement.
• Ability to occasionally lift up to 20 pounds and perform routine laboratory activities involving standing, sitting, walking, bending, and reaching.
• Ability to work safely in a laboratory environment and wear required personal protective equipment (PPE).

Nice To Haves

• Bachelor's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
• One year of relevant laboratory experience for Analyst I.
• Laboratory experience in a pharmaceutical, biotechnology, medical device, academic, research, or other scientific environment.
• For Analyst II, two to three or more years of progressively responsible laboratory experience.
• Experience in a regulated pharmaceutical, biotechnology, medical device, or other GMP environment.
• Demonstrated experience operating analytical laboratory instruments and performing laboratory testing.
• Experience with laboratory investigations, equipment qualification or validation, analytical method validation, or related quality activities.
• Equivalent combinations of education and relevant laboratory experience will be considered.

Responsibilities

• Perform analytical testing of bioanalytical specimens, including blood, urine, and tissue samples.
• Analyze production and research samples using laboratory instrumentation and established analytical techniques.
• Operate, maintain, calibrate, and troubleshoot laboratory equipment and analytical instrumentation.
• Execute analytical methods in accordance with approved Test Methods (TSMs), SOPs, protocols, and validated procedures.
• Document analytical activities, observations, calculations, results, and equipment use accurately and in accordance with applicable requirements.
• Review analytical data for accuracy, completeness, and compliance with established acceptance criteria.
• Identify, investigate, and communicate analytical, equipment, or procedural issues that may affect product quality, compliance, or laboratory efficiency.
• Assist with laboratory equipment qualification, validation, calibration, and maintenance activities.
• Support laboratory investigations, deviations, out-of-specification/out-of-trend investigations, and corrective and preventive actions, as applicable to the position level.
• Assist in preparing, revising, reviewing, and maintaining test methods, SOPs, protocols, reports, and other quality documentation.
• Support Research & Development projects and analytical laboratory investigations.
• Maintain laboratory inventory and Safety Data Sheets (SDS), and assist with purchasing laboratory supplies.
• Complete required training and maintain current training records.
• Participate in continuous improvement initiatives to improve laboratory efficiency, quality, compliance, and reliability.
• Communicate with Quality Assurance, Quality Control, Manufacturing, Research & Development, and other departments as required.
• Perform other duties as assigned.

Benefits

• Up to 4 weeks of paid time off.
• Paid holidays.
• Medical, dental, vision, and prescription coverage for employees and eligible dependents.
• 401(k) retirement plan with employer match.
• Opportunities for professional growth and continued learning.
• Stable, full-time employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level