Quality Control PChem Analyst I or II

Description

 Join Our Team!

Put your laboratory skills to work where quality matters.

Clene is looking for a motivated Quality Control P-Chem Analyst I or II to join our Quality Control team. In this role, you will perform analytical testing on bioanalytical and production samples while helping ensure the quality, safety, integrity, and compliance of our products.

This is an excellent opportunity for a laboratory professional who enjoys hands-on analytical work and wants to grow within a collaborative, science-driven environment focused on quality, continuous improvement, and operational excellence.

The Analyst I or Analyst II level will be based on your education, laboratory experience, technical skills, and demonstrated level of independence.

Excellent Benefits Package
We offer a competitive benefits package, including:

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

Requirements

About the Role
As a Quality Control P-Chem Analyst you will perform analytical testing on bioanalytical and production samples received from contract research organizations, manufacturing operations, and Research & Development.

You will perform testing in accordance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), Standard Operating Procedures (SOPs), validated test methods, and established laboratory procedures.

The position requires strong attention to detail, sound analytical judgment, accurate documentation, and the ability to identify and communicate laboratory or analytical issues that may affect product quality, compliance, or laboratory operations.

Essential Duties and Responsibilities
Your duties and responsibilities will include, but not limited to:

· 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.

· Accurately document analytical activities, observations, calculations, results, and equipment use 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 identity, strength, quality, purity, 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 the preparation, revision, review, and maintenance of test methods, SOPs, protocols, reports, and other quality documentation.

· Support Research & Development projects and analytical laboratory investigations.

· Maintain laboratory inventory, Safety Data Sheets (SDS), and assist with purchasing laboratory supplies.

· Complete required training and maintain current training records.

· Participate in continuous improvement initiatives designed to improve laboratory efficiency, quality, compliance, and reliability.

· Communicate effectively with Quality Assurance, Quality Control, Manufacturing, Research & Development, and other departments as required.

· Perform other duties as assigned.

Education and Experience
Quality Control Analyst I is well suited for an early-career laboratory professional who is ready to build technical skills and gain experience performing analytical testing under established procedures and appropriate supervision.

Preferred qualifications:

· Bachelor's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.

· One (1) year of relevant laboratory experience.

· Laboratory experience in a pharmaceutical, biotechnology, medical device, academic, research, or another scientific environment.

· Equivalent combinations of education and relevant laboratory experience will be considered.

Quality Control Analyst II is an experienced laboratory professional who can perform analytical testing with greater independence, apply sound technical judgment, and contribute to laboratory investigations and quality activities.

Preferred qualifications:

· Bachelor's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific field.

· Two (2) to three (3) or more years of progressively responsible laboratory experience.

· Experience in a regulated pharmaceutical, biotechnology, medical device, or other GMP environment strongly preferred.

· 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 is a plus.

· Equivalent combinations of education and relevant laboratory experience will be considered.

Knowledge, Skills and Abilities
We are looking for someone who brings:

· Working knowledge of cGMP and cGLP requirements.

· Strong analytical, critical-thinking, and problem-solving skills.

· Experience operating and troubleshooting laboratory instrumentation.

· A commitment to accuracy, attention to detail and data integrity.

· The ability to recognize and communicate laboratory, analytical, equipment, and quality issues.

· The 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.

· The ability to work independently while collaborating effectively with a cross-functional team.

· Strong organizational skills and the ability to manage multiple priorities.

· A commitment to laboratory safety, quality, compliance, and continuous improvement. 

Physical Demands
· Ability to occasionally lift up to 20 pounds.

· Ability to stand, sit, walk, bend, reach, and perform routine laboratory activities as required.

· Ability to work safely in a laboratory environment and wear required personal protective equipment (PPE).

Clene is committed to providing reasonable accommodations to qualified individuals with disabilities to enable them to perform the essential functions of the position. 

Schedule
· Consistent weekday schedule.

· Specific hours may vary and are subject to change based on business needs.

Compensation
· $25.00-$28.00 per hour, based on qualifications and experience.

· Full-time employment.

· Opportunities to build technical expertise and grow within Quality Control and pharmaceutical manufacturing.

Ready to Take the Next Step?
If you enjoy hands-on laboratory work, take pride in producing accurate results, and want to continue developing your scientific skills, we would like to hear from you.

Apply today! Submit your resume with your online application and take the next step in your laboratory career with Clene.