Blind Inc.

Job Title: Quality Assurance Specialist

This role with have off shift hours covering our 2nd and 3rd shifts.

• 2nd shift = 2:00pm-10:30pm (Monday-Friday)

• 3rd shift= 10:00pm- 6:30am (Monday-Friday)

Job Description

Job Summary:

• Seeking a talented Quality Assurance Specialist who will play a crucial role in ensuring the integrity of our quality systems and processes. Your responsibilities will include reviewing operations documentation, managing non-conformance and CAPA systems, and supporting various quality assurance functions.

Duties/Responsibilities:

• Review batch records, operations documentation, and other relevant documents to ensure compliance with cGMP, ISO 13485, 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 company's 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/revise SOPs related to Quality Assurance processes.

Qualifications:

Required:

• High School Diploma or GED

• 2-5 years of Quality Assurance/Quality Control experience in a manufacturing environment

• 2-5 years of experience working in a cGMP regulated environment

Preferred:

• 2-year Associate’s or Technical degree with an emphasis in a Quality Control program (preferred)

• Experience in a pharmaceutical environment (preferred)

Work Site

This is a fully on-site position in Saint Paul, Minnesota.

Work Environment

Clean Room Environment

Benefits:

• 401(k)

• 401(k) matching

• Dental insurance

• Flexible spending account

• Health insurance

• Life insurance

• Paid time off

• Tuition reimbursement

• Vision insurance

• 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

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.