Quality Assurance Specialist

As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people's lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Working as one to help many.

POSITION SUMMARY

The Pharma Quality Assurance Specialist assists in assuring that operations at ProMed meet Current Good Manufacturing Practices (cGMP) regulations and customer requirements. The Pharma Quality Assurance Specialist focuses on the quality of all Good Manufacturing Practices (GMP) operations by assisting with internal audits, customer audits, and inspection readiness. The Pharma Quality Assurance Specialist assists in the identification of compliance risks, and ensures that corrective and preventive actions are implemented to support ongoing continuous improvements. The Pharma Quality Assurance Specialist ensures ProMed's brand, philosophy, systems, policies, and procedures are properly implemented and observed. Quality personnel have the authority to halt production if product quality is suspect.

ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following:

• Performs quality assurance activities associated with late phase clinical and commercial cGMP release of drug products, medical devices, and drug/device combination products manufactured at our Plymouth, MN facility;

• Adheres to the Quality Management System and its processes to meet FDA 21 CFR 210, 21 CFR 211, & 21 CFR 820 regulatory requirements, as well as ISO 13485;

• Responsible for review of production records and associated documentation (prior to product release) and assures issues or errors are fully investigated;

• Performs batch and supporting documentation review thoroughly, with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls;

• Provides guidance and represents the Quality Assurance functional area as a subject matter expert (SME) on manufacturing processes development teams;

• Performs review and approval or rejection of controlled documents (procedures, specifications, etc.) that impact product quality;

• Identifies, proposes, and implements Quality Process and system improvements;

• Leads investigation teams and ensures proper close out and follow-up;

• Reviews/approves deviations, investigations, and CAPAs associated with cGMP compliance;

• Initiates, monitors, and reviews/approves change controls related to quality and cGMP topics;

• Represents QA on cross-functional project teams such as manufacturing process development and validation, cleaning validation, and development of technical arguments to support quality decisions;

• Writes new documents and revises existing documents;

• Receives minimal supervision on work assignments;

• Receives overall project direction from management;;

• Participates in internal or supplier audits as needed;

• Meets expectations of regular, reliable attendance;

• Other Duties as Needed: Any other duties and tasks as deemed necessary and appropriate.

QUALIFICATION, EDUCATION & EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelors or Master's Degree in any Life Science discipline preferred, and a minimum of three (3) years' experience in the regulated pharmaceutical industry;

• Must have direct experience with Quality Assurance within the Pharmaceutical Industry and complying with the U.S. Food & Drug Administration (FDA) regulations.

• Knowledge of FDA regulations (21 CFRs 820, 210 & 211), QMS Standard (ISO 13485), and Risk Management standard (ISO 14971);

• Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations;

• Demonstrated experience and proficiency in Microsoft Office applications (Outlook, Word, Excel, and PowerPoint);

• Excellent interpersonal skills and a collaborative management style;

• Excellent verbal, analytical, organizational, writing and presentation and issue-resolution skills; professional, courteous and friendly personality; clearly conveys ideas and information and receives information effectively;

• Excels at operating in a fast-paced, community environment;

• High sense of urgency and strong multi-tasking skills;

• Ability to create positive working relationships with a diverse group of people including gender, ethnicity, age, and cultural and skill level differences;

• Ability to work independently with minimal supervision;

• Ability to establish priorities and meet deadlines.

Preferred:

• Familiarity or experience with the following is strongly preferred: Basic statistics; review/approval of documentation; risk tools; technical writing; and writing/reviewing/approving investigations;

• American Society of Quality (ASQ) Certified Quality Engineer (CQE) or Certified Pharmaceutical GMP Professional (CPGP) preferred;

• Lean Six-Sigma experience preferred.

ProMed offers a generous benefits package including:

• 401k with company match

• Bonus program (similar to profit sharing)

• Medical Insurance

• Health Savings Account/Flexible Spending Account

• Dental Insurance

• Vision Insurance

• Life Insurance

• Short, and Long-Term Disability Insurance

• Critical Illness, Accident, and Identity Theft Protection

• Pet Insurance

ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.