Quality Control Analyst I

DivIHN Integration Inc; Saint Paul (MN); On-site; USD 52,000 - 65,000; Full time

Job summary

DivIHN Integration Inc invites applications for a Quality Control Analyst I, onsite at St. Paul, MN. The role covers analytical testing from raw materials to finished products in a medical device environment.

The ideal candidate will perform biological, chemical, and physical analyses, document results, and support environmental monitoring programs while adhering to cGMP, FDA, and SOP requirements. A bachelor’s in chemistry or biology with analytical coursework is preferred.

Qualifications

• Bachelor’s degree in Chemistry or Biological Sciences with Analytical Chemistry coursework.
• Associates and 2-3 years in med device or pharma background will also be considered.
• Knowledge of cGMP manufacturing is advantageous.

Responsibilities

• Conduct biological, chemical, and physical analyses on medical devices through all stages of manufacturing.
• Perform assays requiring analytical skills and understanding of biology and chemistry principles.
• Maintain data integrity and ensure compliance with SOPs, FDA, GLP, QSR, and cGMP regulations; write exception documents.
• Use laboratory instrumentation and computer systems (e.g., LIMS) to record data.
• Perform audits of laboratory and manufacturing processes as required.

Skills

Multitasking

Communication

English proficiency

Computer literacy

Lab techniques

Data integrity

Education

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

Associates and 2-3 years in med device/pharma background

Tools

LIMS

Job description

Title: Quality Control Analyst I

Location: Onsite at St. Paul, 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.

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

• 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.

Qualifications

• 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.

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.
• Associates and 2-3 years in med device or pharma background will also be considered.
• Appropriate additional certifications may be required pursuant to state or federal regulatory requirements

Interview

• 2 rounds of interview.
• 1st with the hiring manager followed by an onsite interview with the team.

About us

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.