Pharmacy Compound Quality Control Coordinator

Fairview Health Services • Shoreview, MN

11h • Onsite

About The Position

Responsible for performing Quality Assurance and Quality Control functions at the functional/production level. The position will work closely with the Quality Assurance department to ensure all operations and products are correct and completed in a timely fashion.
Location: Seven Lakes Pharmacy 3650 Victoria St N Shoreview, Minnesota 55126-2906
Shift/Hours: Day/8am to 4pm M-F
FTE: 1.0FTE (80 hours/2 weeks)

Requirements

• High School High school diploma or equivalent
• Basic computer skills with knowledge and experience in Microsoft Office (Word, Excel and Power Point)
• Basic knowledge of tools, concepts and methodologies in quality assurance
• Basic technical aptitude with ability to trend and analyze data, provide recommendations, and troubleshoot
• Ability to read and understand technical procedures or government regulations

Nice To Haves

• 3 years Experience in a compounding or manufacturing setting
• 1 year Experience in performing quality assurance functions
• Excellent interpersonal written and verbal communication skills
• Ability to work independently and effectively in a team environment
• Effective organizational and planning skills with the ability to manage priorities and coordinate multiple projects
• Excellent problem solving skills
• Knowledge in cGMP and/or GCP compliance
• Ability to show initiative, exercise sound judgement, and work with high level of accuracy and attention to detail

Responsibilities

• Assist in quality assurance efforts, including but not limited to: Support the change control process and new product development.
• Assisting quality assurance in preparation, review, and maintenance of manufacturing processes, quality documents, and non-conformance activities as needed.
• Initiating and monitoring product test data including stability studies and batch release testing.
• Assisting managers and Quality Assurance in training new staff and continuing competency assessments.
• Providing content input and review of SOPs related to assigned quality functions, as a subject matter expert (SME) – especially as related to their assigned quality functions.
• Completing and performing review of quality documents and records related to their assigned quality functions. If authorized, they may perform issuing of labels and controlled record forms.
• Managing production samples pulled for quality control testing. Notifying QAU of any discrepancies or non-conformance for the activities related to their assigned quality functions.
• Performing other documentation review functions for quality documentation such as batch records, logbooks, labels, etc., as assigned.
• Participating in non-conformance activities as determined by the specific event as needed. May be authorized to issue events, batch non-conformance forms and manage non-conformance logs.
• Participating in regulatory inspections as a potential part of the audit team or as SMEs for their quality activities as required during the inspection.
• Participating in audit activities as needed per their specific quality job function.
• Issuing and reviewing quality questionnaires for newly identified potential critical suppliers as needed.
• Collecting data and recording for their quality activities as required.
• Notifying QAU if data exceeds limits or if trends are seen which may require additional evaluation and action. May be authorized to perform trending activities for their quality activities.
• Participating in activities related to client complaints, adverse events, and recalls as defined by their quality activities.

Benefits

• Fairview offers a generous benefit package including but not limited to medical, dental, vision plans, life insurance, short-term and long-term disability insurance, PTO and Sick and Safe Time, tuition reimbursement, retirement, early access to earned wages, and more!
• Please follow this link foradditional information: https://www.fairview.org/careers/benefits/noncontract

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED