Quality Control Analyst I- Kronos

Planet Pharma; Saint Paul (MN); On-site; USD 26,000 - 36,000; Full time

Job summary

Planet Pharma in Minnesota seeks an analytical technician to perform biological, chemical and physical analyses on medical devices through all stages of manufacturing.

The role requires attention to detail, strong English communication, and the ability to use LIMS and laboratory instrumentation while ensuring data integrity and regulatory compliance.

Qualifications

• Bachelor's degree in Chemistry or Biological Sciences with Analytical Chemistry or Laboratory coursework.
• 0-2 years experience in a laboratory environment.
• Must read, write and converse in English.
• Knowledge of cGMP manufacturing and lab safety procedures.
• Ability to handle multiple tasks and maintain data integrity.

Responsibilities

• Perform biological, chemical and physical analyses on materials, in-process and final products, and environmental samples.
• Use laboratory instrumentation and LIMS to collect and record data.
• Conduct testing and timely completion of protocols and projects.
• Maintain data integrity and comply with SOPs and regulatory requirements (FDA, GLP, QSR, cGMP).
• Write exception documents and participate in audits and continuous improvement activities.

Skills

Attention to detail

Reading comprehension

English communication

Teamwork

Laboratory instrumentation

cGMP knowledge

Data entry

Computer literacy

Education

Bachelor's degree in Chemistry or Biological Sciences with Analytical Chemistry

Tools

LIMS system

Job description

Pay range: 19-26/hr
*depending on exp

Summary: 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

• The incumbent will perform other duties assigned.
• 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.
• 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.

Qualifications

• 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.
• 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

Education and/or Experience

• Bachelors 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