Quality Control Specialist - 2nd Shift

Job Description

Job Description

Quality Control Specialist- 2nd Shift 3 : 00PM to 11 : 30 PM

Why Work for Us

At our OptioRx, you’re more than just an employee — you’re part of a team that values growth, support, and success. We partner with Insperity our PEO to offer comprehensive benefits including medical, dental, and vision coverage, a generous matching 401(k) to help you plan for the future, and so much more. That includes perks for your wellbeing.

What truly sets us apart is our commitment to our people. We believe in recognizing talent, rewarding dedication, and promoting from within so you can build a lasting career with us. If you’re motivated, driven, and ready to make a difference, this is the place where your hard work will truly pay off.

POSITION SUMMARY- 2nd Shift

3 : 00PM to 11 : 30PM

The Quality Control Specialist at SBH Medical / OptioRx will play a critical role in ensuring compliance with quality standards, regulatory requirements, and internal policies for our 503A compounding pharmacy operations. This individual will be responsible for quality oversight of batch record review, compliance documentation, product disposition, and quality system performance. The role requires a detail-oriented professional with expertise in quality assurance, risk management, and compliance monitoring within the pharmaceutical or biotechnology industry.

ESSENTIAL FUNCTIONS

• Support the reporting of Quality metrics on a monthly and quarterly basis for management reviews and key performance indicators (KPIs) related to 503A compounding pharmacy operations.
• Assist in implementing and maintaining quality risk management frameworks.
• Perform batch record reviews and product dispositions in support of testing, validation, and compounding product distribution.
• Evaluate compliance of completed compounding records, including batch records, Certificates of Conformance (COC), Certificates of Analysis (COA), and other related data.
• Maintain real-time Continued Process Verification data collection at batch release.
• Review and manage Quality System documentation, including deviations, Out of Specification (OOS) reports, product complaints, Corrective and Preventive Actions (CAPAs), and document / change control processes.
• Evaluate and ensure compliance requirements for document changes, including SOPs and Master Batch Records.
• Analyze and report on product and process quality trends, as well as quality system performance against internal and external regulations.
• Provide Quality Assurance (QA) oversight to ensure compliance with required quality standards.
• Collaborate with the General Manager, Staff Pharmacists, and Director of Quality to enhance compliance with quality systems, internal SOPs, and regulatory requirements, while resolving minor and major deviations.
• Support product complaint-handling activities and the preparation of the Annual Product Quality Report.
• Assist with compliance audits of supplier quality systems.
• Conduct and support employee training related to quality processes as needed.
• Lead investigations related to deviations, OOS findings, and QC testing, implementing CAPAs and change controls.
• Perform timely quality reviews of data associated with batch releases to meet operational and business requirements.
• Ensure compliance with regulatory requirements concerning product safety and quality.
• Provide oversight for investigations, including writing and reviewing investigation reports.
• Oversee equipment / software qualification, calibration, and validation processes.
• Prepare quality documents such as SOPs and technical documents, and conduct investigations, reviews, and approvals for OOS reports, Change Controls, Deviations, and Complaints.
• Foster a quality culture and adherence to corporate values through coaching, mentoring, and leadership.
• Conduct audits of APIs, excipients, packaging, or related manufacturing processes while ensuring compliance with relevant regulations (USP 795, USP 797, USP 800, FDA, State Boards of Pharmacy, NABP VPP, ACHC).
• Perform product disposition activities, including document review and approval, archival of records, and raw data review.
• Any other duties as assigned.

QUALIFICATIONS

Physical Requirements