Job Title: Quality Assurance Specialist (Direct Hire)
Job Description

• Our client is a company that collaborates with pharmaceutical companies to develop and produce innovative medication delivery systems, such as skin patches, oral thin films, and wearable medical devices. They are seeking a talented Quality Assurance Specialist to play a crucial role in maintaining the integrity of their quality systems and processes. This full-time, on-site role is located in West St. Paul, MN, with working hours from Monday to Friday, 8:00 AM to 4:30 PM.

Responsibilities

• Review batch records, operations documentation, and other relevant documents to ensure compliance with cGMP, ISO, EU, FDA regulations, company procedures, and customer needs.
• Investigate and resolve discrepancies in manufacturing documentation.
• Communicate with customers to address their concerns and ensure timely product release.
• Implement and manage the Non-conformance and CAPA system.
• Support the Material Review Board in resolving non-conformances, customer complaints, and implementing corrective actions.
• Provide cross-functional support to Quality, Engineering, Operations, and Purchasing on investigations and corrective action reports.
• Initiate and write investigation reports for MRRs and incidents.
• Utilize effective CAPA and Root Cause Analysis tools during investigations.
• Provide training and support to colleagues on quality assurance procedures and systems.
• Back up other Quality Assurance Specialists and Documentation Specialists as needed.
• Author and revise SOPs related to Quality Assurance processes.
• Participate in various projects to meet company and customer quality requirements.

Essential Skills

• 2-year technical degree required; 4-year technical degree preferred.
• 2-5 years of Quality Assurance/Quality Control experience in a manufacturing environment, preferably in the medical device or pharmaceutical industry.
• 2-5 years of experience working in a cGMP regulated environment.
• Strong experience in complaint investigations.
• Knowledge of cGMP, 21 CFR 210, 211, 820, ISO, and other FDA regulations.
• Proficiency in MS Office Suite and applicable QMS software.
• Effective written and verbal communication skills.
• Strong problem-solving and analytical skills.

Additional Skills & Qualifications

• Strong ability to work independently and manage multiple projects simultaneously.
• Excellent attention to detail and accuracy.
• Ability to train and coach others.

Why Work Here?
We offer annual salary adjustments for meeting or exceeding job performance, a 401K match plan with a 62.5% match of every dollar invested up to 6% of annual salary, and a comprehensive holiday pay plan based on years of service. Our continuing education plan provides up to $5,250 per calendar year for eligible employees for coursework at accredited institutions. Additionally, we offer a robust insurance package, including 401(k) matching, dental insurance, flexible spending accounts, health insurance, life insurance, paid time off, tuition reimbursement, and vision insurance.
Work Environment
The work environment includes a cleanroom setting, adhering to strict cleanliness and safety standards. The role is full-time and on-site with regular working hours from Monday to Friday, 8:00 AM to 4:30 PM.
Job Type & Location
This is a Permanent position based out of Saint Paul, Minnesota.
Pay and Benefits
The pay range for this position is $62000.00 - $70000.00/yr.
Salary Adjustments - annual increases for meeting or exceeding job performance
401K Match plan - 62.5% match of every dollar invested up to 6% of annual salary
Holiday Pay:
1-5 years = 80 hours
6-11 years = 120 hours
12-25 years = 160 hours
25+ = 200 hours
Continuing education plan/tuition assistance:
The company will provide educational assistance in the form of reimbursement to eligible employees up to a maximum of $5,250 per calendar year, for coursework at a degree or certificate granting institution at either high school, vocational, college or graduate level.
Strong insurance package -
Benefits:
-401(k)
-401(k) matching
-Dental insurance
-Flexible spending account
-Health insurance
-Life insurance
-Paid time off
-Tuition reimbursement
-Vision insurance
Workplace Type
This is a fully onsite position in Saint Paul,MN.
Application Deadline
This position is anticipated to close on Mar 26, 2025.
About Aerotek:
We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry - from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies' construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow.
Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.