Summary | STAQ Pharma is a 503B Outsourcing Facility located on the west side of Columbus, OH. STAQ Pharma produces sterile injectable medications for adults and pediatric patients, compounded under cGMP standards. STAQ’s ownership and board are composed of large hospital systems ensuring the priority focus remains on delivering needed medications in a safe and timely manner. We are looking for exception people to join the STAQ team. This role is responsible for leading all Quality Control (QC) activities at the site. The QC Manager will encourage and motivate associates to be successful and focused on Safety, Transparency, Availability, and Quality (STAQ) objectives. A great fit for this role is an individual with 5+ years of microbiology experience supporting pharmaceutical and manufacturing activities. |
Roles and Responsibilities | - Establish an environmental monitoring program for the facility utilizing a risk-based approach to new and existing procedures.
- Develop, manage, and improve QC processes and procedures to ensure compliance with all applicable laws, regulations, and STAQ Quality standards in support of cGMP standards for pharmaceutical manufacturing (503B).
- Prepare, review, manage, and approve controlled documents (SOPs, protocols, logbooks, reports, etc.) relevant to STAQ QC operations.
- Lead and draft investigations/deviations/change controls/OOS/CAPAs as they relate to environmental monitoring or Quality Control deviations.
- Provide expertise and support to the Operations, Regulatory, and Quality teams.
- Subject matter expert during audits or inspections as it relates to microbiology/environmental monitoring.
- Recruit, retain, and mentor direct reports to comprise the QC team. Promote personal and professional growth of team members.
- Support the batch disposition process including management of reserve samples and QC samples for batch release testing.
- Manage the budget for the QC Lab department to meet financial objectives.
- Lead the Stability Program including study management, protocol development & evaluation, timely completion of stability tests, data trending, etc.
- Collect, submit, ship, and manage appropriate raw material, microbiological and finished goods samples to third party testing laboratories.
- Coordinate and facilitate operations within the internal laboratory to ensure Environmental Monitoring samples are performed, tested, reviewed, and trended appropriately.
- Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility. Analyze and interpret trends and identify opportunities to improve processes and achieve state of control.
- Focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up, and ability to make timely and sound decisions.
- Implement methods of continuous improvement in daily work and in evaluation of company processes and performance.
- Other duties as assigned.
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Preferred Qualifications and Education | - B.S. or B.A. in Microbiology or a closely related field / or equivalent experience.
- Minimum five (5) years’ experience in a quality control environment.
- Experience in a cGMP pharmaceutical/aseptic manufacturing environment.
- Must demonstrate understanding and/or working knowledge of regulations/guidelines such as FDA, USP, ICH, etc.
- Proficiency/experience with environmental monitoring program for aseptic manufacturing facility, including personnel monitoring, and qualification program.
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