Mid Level Quality Control Specialist Jobs

POSITION SUMMARY

Shift 1 (7:00 AM 3:30 PM) M-F

The Quality Control Specialist at 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 industries.

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

• Bachelor’s degree in science or equivalent relevant experience
• CPhT - Required
• 3+ years of combined quality experience in 503A drug product compounding, process development, commercial manufacturing, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries
• Working knowledge and/or understanding of quality risk assessment management principles
• experience with Quality Assurance systems and processes
• Effective organization and planning skills
• Demonstrated ability to deal with frequent changes, delays, or unexpected events
• Strong technical writing skills
• Demonstrated troubleshooting and problem-solving techniques
• Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups
• Proven ability to work independently and under tight deadlines and pressure in a composed manner
• Effective interpersonal and communication skills
• Comfortable communicating with all levels of staff, including executives
• Strong team player
• Actively take the lead in ensuring corporate compliance and set strategy in investigations and CAPAs, as necessary.
• Participate and/or lead meetings, to provide input on timelines, potential compliance issues and other related QC activities.
• Able to build and sustain highly functioning teams, cohesive, aspiring for shared and individual goals in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.
• Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
• Ability to aseptically gown and/or sterile gown as needed
• Ability to work within environmental clean rooms
• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
• PHYSICAL REQUIREMENTS

● Ability to Sit for Extended Periods: Comfortable sitting at a workstation and working on a computer for extended durations as part of daily responsibilities.

Job Type: Full-time

Pay: $24.00 - $26.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Work Location: In person