Quality Pharmacist Job at STAQ Pharma, Columbus, OH

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  • STAQ Pharma
  • Columbus, OH

Job Description

Job Summary:

The Quality Pharmacist supports quality operations in a 503B outsourcing facility, ensuring all compounded sterile preparations meet regulatory and company quality standards. This entry-level role provides exposure to quality assurance, regulatory compliance, and compounding oversight under cGMP and FDA guidelines. The position assists with documentation review, investigations, and audits while promoting a culture of safety and continuous improvement within pharmaceutical operations

 

Responsibilities: 

  • Review batch records and documentation for accuracy, completeness, and compliance with SOPs and cGMP.
  • Support environmental monitoring, media fills, and sterility assurance activities.
  • Participate in deviation investigations, corrective and preventive actions (CAPA), and change control processes.
  • Assist in internal and external audit preparation and responses.
  • Verify labeling, packaging, and final product release documentation.
  • Complete annual product reviews.
  • Submit biannual reporting to FDA for compounded products.
  • Obtain and maintain pharmacist licensure in multiple states.
  • Support maintenance of compliance with FDA, DEA, USP <797>/<800> , and state board of pharmacy regulations.
  • Assist in maintaining facility and product licenses and registrations.
  • Participate in periodic reviews of standard operating procedures and quality documentation.
  • Ensure documentation practices meet FDA 503B outsourcing facility standards.
  • Identify opportunities for process improvement and operational efficiency.
  • Support quality metrics reporting and trending of deviations or customer complaints.
  • Assist in training staff on quality systems, GMP documentation, and aseptic techniques.
  • Collaborate cross-functionally with operations, production, and R&D to maintain a compliant environment.
  • Provide quality-related guidance during daily production activities and support troubleshooting efforts.
  • Promote a culture of compliance, accountability, and continuous learning throughout the organization.

 

 

Required Skills/Abilities:

  • Strong understanding of pharmaceutical compounding and cGMP fundamentals.
  • Excellent organizational, analytical, and problem-solving skills.
  • Strong written and verbal communication abilities.
  • Proficiency with Microsoft Office and familiarity with electronic quality management systems (QMS).
  • High attention to detail and ability to manage multiple priorities.
  • Willingness to learn regulatory compliance principles for 503B operations.
  • Excellent time management skills with a proven ability to meet deadlines.
  • Strong analytical and problem-solving skills.
  • Strong supervisory and leadership skills.
  • Ability to prioritize tasks and to delegate them when appropriate.
  • Ability to function well in a high-paced and at times stressful environment.
  • Proficient with Microsoft Office Suite or related software.

 

Education and Experience:

  • Doctor of Pharmacy (PharmD) degree required.
  • 0–2 years of experience in a compounding pharmacy or cGMP-regulated pharmaceutical setting (internship or rotation experience acceptable).
  • Knowledge of USP <797> , <800> , and FDA guidance for outsourcing facilities preferred.
  • State pharmacist license in good standing required (or eligibility for licensure).

 

Requirements:

  • Pharmacist will apply for licensure in any state(s) that STAQ requests them to do so, at STAQ’s cost and expense. 
  • Pharmacist will allow STAQ to use their license for any site in which STAQ is licensed or applying to be licensed. 

 

Physical Requirements: 

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times. 

 

Job Tags

Work at office,

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