Quality Control Analyst I

Stark Pharma Solutions Inc; Saint Paul (MN); On-site; USD 52,000 - 78,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Quality Control Analyst I in Minnesota to perform biological, chemical, and physical testing of medical device materials and products throughout the manufacturing process.

You will support testing of incoming raw materials, in-process and finished products, and environmental monitoring samples while ensuring compliance with laboratory procedures and regulatory requirements.

Qualifications

• Bachelor's degree in Chemistry, Biology, Biological Sciences, or related Life Sciences with analytical coursework.
• 0–2 years of experience in a laboratory, quality control, pharmaceutical, biotechnology, or medical device environment.
• Familiarity with cGMP manufacturing and regulated laboratory environments.
• Familiarity with LIMS or other laboratory computer systems.

Responsibilities

• Perform biological, chemical, and physical analyses of raw materials, in-process materials, finished products, and environmental monitoring samples.
• Operate laboratory instruments and computer systems to perform testing and maintain accurate records, including use of LIMS.
• Perform laboratory assays requiring knowledge of basic biology, chemistry, and analytical principles.
• Maintain data integrity and ensure compliance with company SOPs, specifications, FDA, GLP, QSR, and cGMP requirements.
• Review and update SOPs and other laboratory documentation when needed.
• Participate in cross-functional initiatives focused on problem-solving, process improvement, efficiency, cost savings, and quality improvement.

Skills

Attention to detail

Data integrity

Documentation skills

Team collaboration

SOP adherence

Education

Bachelor's degree in Chemistry, Biology, Biological Sciences, or related Life Sciences

Tools

LIMS

Analytical instruments

Autoclaves/Incubators

Job description

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Job Title: Quality Control Analyst I

Location: Minnesota

Duration: Long Term

Job Summary

We are seeking a Quality Control Analyst I to perform biological, chemical, and physical testing of medical device materials and products throughout the manufacturing process. The role will support testing of incoming raw materials, in-process and finished products, as well as environmental monitoring samples while ensuring compliance with laboratory procedures, quality standards, and applicable regulatory requirements.

Key Responsibilities

• Perform biological, chemical, and physical analyses of raw materials, in-process materials, finished products, and environmental monitoring samples.


• Operate laboratory instruments and computer systems to perform testing, collect data, and maintain accurate records, including use of LIMS.


• Perform laboratory assays requiring knowledge of basic biology, chemistry, and analytical principles.


• Complete routine, special project, and protocol testing accurately and within required timelines.


• Maintain data integrity and ensure compliance with company SOPs, specifications, FDA, GLP, QSR, and cGMP requirements.


• Prepare and document laboratory exception reports and support investigations as required.


• Participate in cross-functional initiatives focused on problem-solving, process improvement, efficiency, cost savings, and quality improvement.


• Perform laboratory and manufacturing audits as required.


• Review and update SOPs and other laboratory documentation when needed.


• Perform basic laboratory equipment maintenance and calibration activities as required.


• Follow applicable chemical and biological safety procedures and laboratory practices.


• Maintain accurate and complete testing and laboratory documentation.


• Work effectively with Quality, Manufacturing, Laboratory, and other cross-functional teams.

Basic Qualifications

• Bachelor's degree in Chemistry, Biology, Biological Sciences, or a related Life Sciences field with relevant analytical chemistry or laboratory coursework.


• 0 2 years of experience in a laboratory, quality control, pharmaceutical, biotechnology, or medical device environment.


• Basic understanding of laboratory instrumentation and analytical testing principles.


• Knowledge of basic chemical and biological laboratory safety procedures.


• Familiarity with cGMP manufacturing and regulated laboratory environments.


• Experience with laboratory equipment such as autoclaves, incubators, and analytical instruments is preferred.


• Familiarity with LIMS or other laboratory computer systems is preferred.


• Strong attention to detail, reading comprehension, documentation, and organizational skills.


• Ability to manage multiple tasks and complete testing activities within required timelines.


• Strong written and verbal communication skills with the ability to work effectively in a team environment.


• Ability to read and follow detailed written procedures and instructions.


• Strong commitment to data integrity, quality, compliance, and continuous improvement.


• Good written and verbal communication skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.