Quality Control Analyst

Stefanini Group; Saint Paul (MN); On-site; USD 29,000 - 40,000; Full time

Benefits offered by this job

10 PTO

Job summary

Stefanini Group seeks a Quality Control Analyst for an onsite role in Saint Paul, MN.

The position involves conducting biological, chemical, and physical analyses across the manufacturing process, using LIMS for data capture and ensuring compliance with FDA, GLP, and cGMP standards.

Qualifications

• Bachelor’s degree in chemistry or Biological Sciences with Analytical Chemistry coursework.

Responsibilities

• Conduct biological, chemical, and physical analyses across the manufacturing process (raw materials to finished goods).
• Use laboratory instrumentation and LIMS to collect and record data.
• Perform assays requiring analytical chemistry knowledge and precise technique.
• Maintain data integrity and ensure compliance with SOPs, FDA, GLP, QSR and cGMP regulations.
• Audit and update plant SOPs; participate in cost savings and quality improvements.

Skills

Biology

Analytical Chemistry

Laboratory instrumentation

LIMS

Education

Bachelor’s degree in Chemistry

Tools

LIMS

Job description

Job Title: Quality Control Analyst (Onsite role)

Location: St. Paul, MN 55114

Duration: 12 months Contract (Temp. to hire)

Timing: 06:00 AM - 03:30 PM shift (Monday and Friday)

Pay rate: $25/- hourly on W2 with 10 PTO

Job Description:

Conduct specific biological, chemical, and physical analyses on medical devices through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs.

Essential Duties and Responsibilities:

• Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at manufacturing facilities, etc.
• Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
• May perform equipment maintenance and calibrations as required.
• May perform other duties as assigned.

Job Requirements:

• Bachelor’s degree in chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework with 0-2 years' experience.
• Appropriate additional certifications may be required pursuant to state or federal regulatory requirements.
• Ability to handle multiple tasks concurrently, and in a timely fashion.
• Must be detail oriented, conscientious and have high reading comprehension skills.
• Must have basic understanding of laboratory instrumentation.
• Must be able to communicate effectively with supervisors and peers.
• Must be able to read, write, and converse in English.
• Must be able to navigate, conduct searches, and fill online forms on Personal Computer for the purposes of training, performance management, and self-service applications.
• Must have the ability to navigate electronic mail systems and intranet for communication purposes.
• Good interpersonal skills and be able to work effectively and efficiently in a team environment.
• Knowledge of cGMP manufacturing.
• Knowledge of basic laboratory production equipment including, but not limited to autoclaves, incubators, analytical equipment.
• Knowledge of basic chemical and chemical safety procedures.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage, and conviction.
• Must have passion to innovate and drive for solutions.
• Must display personal accountability for results and integrity.
• Must display eagerness to learn and continuously improve.
• Must have uncompromising dedication to quality.

Best regards,

Rachit Rastogi (Rick)