Pharmacy Compound Quality Control Coordinator

Job Overview

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

Shift/

Hours:

Day/8am to 4pm M-F

FTE: 1.0

FTE (80 hours/2 weeks)

• 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.
  
  Required Qualifications
  • 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
  Preferred Qualifications
  • 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
  Benefit Overview

  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 for additional information: https://(Use the "Apply for this Job" box below)./noncontract

  Compensation Disclaimer

  An individual's pay rate within the posted range may be determined by various factors, including skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization prioritizes pay equity and considers internal team equity when making any offer. Hiring at the maximum of the range is not typical. If your role is eligible for a sign-on bonus, the bonus program that is approved and in place at the time of offer, is what will be honored.

  EEO
  
  Statement

  EEO/Vet/Disabled:
  All qualified applicants will receive consideration without regard to any lawfully protected status