Senior Quality Assurance Specialist (ProMed Pharma) - ProMed Molded Products, Inc.

As a Sr. Quality Assurance Specialist working on our team, you will apply your expertise to both medical device and drug products as well as combination products. This position could be a great opening for a person currently in the pharmaceutical industry to break into the medical device industry and be a subject matter expert regarding drug GMPs.

OBJECTIVES:

• Perform Quality Assurance activities associated with commercial cGMP controlled release and combination drug products manufactured at our Plymouth, MN facility.
• Responsible for review of batch records and associated documentation in support of timely commercial drug substance batch disposition.
• Provides guidance and represents the Quality Assurance functional area as a subject matter expert (SME) on manufacturing processes development teams.

ACCOUNTABILITIES:

• 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.
• Supports GMP compliance by leadership and example with the Operations team on a regular basis.
• Performs QA review/approval of controlled documents.
• Analyzes and interprets projects, studies, or investigations to determine next steps. Makes decisions independently and notifies management of action taken.
• Identifies, proposes, and implements Quality Process and system improvements.
• Identifies, investigates, and resolves complex technical issues using problem-solving skills. Notifies management of actions taken.
• Leads investigation teams and ensures proper close out and follow up.
• Develops and provides training on department-specific procedures/systems and quality-related topics from industry.

• Reviews/approves deviations, investigations, and CAPAs associated with cGMP compliance. Initiates, monitors, and reviews/approves change controls related to Quality and GMP topics.
• Represent 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, independently.
• Receives minimal supervision on work assignments. Receives overall project direction from management, but completes most work independently.
• Participates in internal or supplier audits as needed.
• Performs additional duties, as assigned.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• BA/BS (or Master's) in any Life Science discipline preferred, and/or 8+ years’ experience in Regulated pharmaceutical industry.
• Must have direct experience with Quality Assurance within the Pharmaceutical industry.
• Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations.
• Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and Writing/reviewing/approving investigations
• Ability to handle multiple tasks and competing prioritiesconcurrently and in a timely fashion.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Demonstrated experience making sound independent decisions.
• Excellent verbal and written communication skills.
• Must be able to read, write, and converse in English.
• Must display eagerness to learn and continuously improve.
• Positive work attitude that supports teamwork and continuous improvement.
• Demonstrated experience and proficiency in Microsoft Office applications; Word, Excel and PowerPoint.

LICENSES/CERTIFICATIONS:

• ASQ Certified Quality Engineer (CQE or CPGP) preferred
• Lean Six-Sigma experience preferred

PHYSICAL DEMANDS:

• Standing or sitting > Must be able to remain in a stationary or standing position for extended periods of time.
• Repetitive motion > wrist and hand motion (e.g. typing, writing)
• Must be able to work in controlled or clean room environments requiring special gowning.

OTHER REQUIREMENTS:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Willingness to travel to various meetings or training, this could include overnight trips.
• Requires approximately 5% travel.