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.