This Quality Control Analyst II position offers a direct path for an experienced STEM professional to expand their technical expertise within a high-impact cGMP manufacturing environment. Based at the Brooklyn Park site, you will play a vital role in facility safety by performing Environmental Monitoring (EM) and Critical Utility testing. You will gain hands-on mastery of specialized instrumentation like Charles River Endoscan and MODA while ensuring the sterility of manufacturing cleanrooms through rigorous aseptic techniques. This is an ideal role for an analyst with a strong laboratory foundation who is ready to take on more responsibility in SOP management and data integrity while contributing to the delivery of life-changing therapeutics.
location: Minneapolis, Minnesota
job type: Contract
salary: $30.00 - 35.33 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Environmental & Utility Monitoring: Conduct test methods for samples generated for facility monitoring, including Environmental Monitoring (EM) and Critical Utilities.
Cleanroom Operations: Work within the laboratory environment for extended periods conducting facility monitoring (EM and Critical Utility Monitoring) and product tests.
Test Execution: Independently execute and review routine in-process, drug substance, and stability test methods in a timely manner.
Instrumentation & LIMS: Use laboratory instrumentation and computer systems such as LIMS, Charles River Endoscan, and MODA to collect and record data.
Operational Maintenance: Maintain lab operations including cleaning, ordering of supplies, reagent preparation, stocking, and waste disposal.
SOP Management: Author new SOPs and initiate changes to existing procedures to ensure laboratory efficiency and compliance.
Staff Training: Train new QC Analysts on routine procedures and practices.
Equipment Care: Perform equipment maintenance and calibrations as required.
Data Integrity: Maintain data integrity and ensure strict compliance with company SOPs, specifications, and cGMP regulations. Shift Flexibility: May be required to work overtime or be assigned to a different shift as needed
qualifications:
Required:
- Bachelors or Masters degree in any Life Sciences with relevant laboratory coursework
- QC Micro Skill Set - This could include: Contamination control, Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems
- Must understand laboratory instrumentation.
- Knowledge of cGMP manufacturing
- Knowledge of biological and/or microbiological safety procedures.
- 3-6 years of relevant experience.
- Previous experience in a regulated environment.
skills: Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Capillary Electrophoresis (CE), Gel Electrophoresis (SDS-PAGE), Enzyme-Linked Immunosorbent Assay (ELISA), Aseptic Technique, SOP Development, Corrective and Preventive Actions (CAPA), Quality Control (QC)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
