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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
· Bachelor’s degree in science or equivalent relevant experience
· 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
· Must be able to obtain pharmacy technician certification within six (6) months of hire
Physical Requirements
● On‑site role at Enovex Pharmacy; up to ~15% travel to other OptioRx locations for audits, training, or inspections.
● Gowning/PPE required for cleanroom entry; frequent walking/standing during observations; occasional lifting up to 25 lb.
● Must be able to sit for extended periods of time
● Must be able to look at vials with light box for extended periods of time.
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
· Bachelor’s degree in science or equivalent relevant experience
· 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
· Must be able to obtain pharmacy technician certification within six (6) months of hire
Physical Requirements
● On‑site role at Enovex Pharmacy; up to ~15% travel to other OptioRx locations for audits, training, or inspections.
● Gowning/PPE required for cleanroom entry; frequent walking/standing during observations; occasional lifting up to 25 lb.
● Must be able to sit for extended periods of time
● Must be able to look at vials with light box for extended periods of time.