This position supports IntegraDose production by ensuring that manufacturing operations are in compliance with the cGMP standards promulgated under Sections 503B of the US Food, Drug & Cosmetic Act. The Quality Assurance Specialist/Analyst accomplishes this by assisting the Quality Program Manager with establishing, implementing, and maintaining quality management system functions.

Collaborates with the Quality Manager in establishing, implementing, and maintaining the quality management systems, including:

• Executing quality systems activities such as generating metrics and evaluating trends.
• Performing investigations and Root Cause Analysis (RCA) and implementing effective Corrective Action and Preventative Actions (CAPA) which address operational and system issues.
• Maintaining CAPA system for compliance, including monitoring open CAPAs for timely review/closure.
• Conducting internal audits, including creating audit finding reports, determining proper corrective and preventive actions, and closing out audit findings/activities.
• Developing and performing staff training in quality functions to build quality awareness.
• Assisting in product recall and notification activities.

Partners with Production providing support for efficient and successful manufacturing of product, including:

• Generation and control of production records, such as batch records, labels, and disposition records.
• Performing cGMP review of completed manufacturing records and analytical testing results, including reconciliation and archiving.
• Generating and maintaining documentation to support validations, stability studies, and commercial production.
• Supporting environmental monitoring (EM) functions by generating event records, evaluating and trending test data, and providing notification of excursion events to production and management.

Provides support and oversight for IntegraDose document control systems, including:

• Creating and maintaining quality system documentation, such as policies and procedures, SOPs, work instructions, and validation plans.
• Facilitating staff reviews and updates, generating final audit archival tools and securing approvals.
• Managing quality system electronic logs, issuing related document numbers, and managing revision numbers (revision control).

Supports purchasing/supply chain functions, including:

• Maintaining the approved critical vendor lists and managing supplier performance evaluation through quality questionnaires.
• Releasing incoming critical raw materials and supplies for production use.
• Performing supplier audits when required.

Maintains oversight and management of the equipment program, including:

• Managing the equipment log, assigning and issuing equipment numbers.
• Performing IQ/OQ/PQ review and approval.
• Maintaining the maintenance and calibration schedule, coordinating activities and timelines with the QC equipment.

RequiredEducation

• Bachelors degree in Science, Microbiology, or Engineering or related field and/or 6 years of equivalent experience.

RequiredExperience

• 3 years of progressive experience within cGMP quality operations and FDA regulated environments
• Strong understanding of 21 CFR Part 210/211 requirements and knowledge of tools, concepts and methodologies of quality assurance and compliance systems, e.g. FDA, MN BOP, DEA
• Familiarity with manufacturing process and operations, automation, equipment/facilities validation
• Excellent written and verbal communication skills
• Strong organizational, analytical, and problem solving skills
• Strong computer skills database management and documentation preparation (Word, Excel, Power point)
• Ability to work independently, with minimal instruction or supervision
• Ability to show initiative and work with high level of accuracy and attention to detail.
• Effective organizational and planning skills with the ability to manage priorities and coordinate multiple projects simultaneously

Preferred Experience

• 1 2 years experience within a pharmaceutical laboratory or manufacturing environment
• Experience within a 503B outsourcing facility and/or aseptic/parenteral manufacturing environment

License/Certification/Registration

• ASQ Certification in Quality Improvement Associate, or similar
• ISO 9001 (or ISO 17025) Internal Auditor Certification

This position requires remote work. In addition to adhering to all M Health Fairview policies, guidelines, procedures, the M Health Fairview Commitments, and the Code of Conduct, it is the expectation the following requirements of the remote work policy will be met, including but not limited to:

• Remote workspace that is clean, safe,andprofessional.
• Maintains an internet connection consistent with Fairview standards at remote workspace.
• Remain productive and responsive during their scheduled work hours.
• Attend primary Fairview location, as needed.