Quality Pharmacist

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.