Quality Control Analyst

Title:

Quality Control Analyst I

Location:
Onsite l, MN

Duration: 12 Months with possible extension

Schedule:
Monday - Friday 6:00 AM - 3:30 PM

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

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.

• Entry level role
• The incumbent will perform other duties assigned.
• The candidate provides Biology, Microbiology support.
• 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 the 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; write exception documents.
• 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.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Ability to handle multiple tasks concurrently and in a timely fashion.
• Computer literate. 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 on line 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 biological safety procedures.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Will perform Bioburden, Endotoxin, Seal Strength, Autoclaving operations.
• Nice to have LIMS.
• Prefer someone who has exposure to the Environmental Monitoring and used autoclaves, biological safety cabinet.
• Nice to have Clean room gowning and Material Transfer experience.
• Pipetting and working on a aseptic environment is beneficial.

• 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

• Bachelors Degree in Chemistry, or Biological Sciences…