Quality Assurance Manager

PharmaLogic; Columbia Township (MO); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

401(k) retirement benefit program

Medical

Dental care

Disability insurance

Employee assistance program

Extended health care

Life insurance

On-site parking

Paid time off

Vision care

Job summary

PharmaLogic is seeking a Site Quality Assurance Manager in Columbia Township, Missouri. The ideal candidate will ensure compliance with cGMP regulations and oversee production quality for PET radiopharmaceuticals. Responsibilities include managing quality-related issues, leading FDA audits, and maintaining training and documentation. A BS/BA in a scientific discipline and 3-5 years of experience in the pharmaceutical industry are essential. Benefits include health insurance, 401(k), and paid time off.

Qualifications

• Minimum of 3-5 years quality experience in the pharmaceutical industry.
• Pharmacy tech certification is a plus.
• Experience with aseptic technique and ionizing radiation is desirable.
• Strong knowledge of cGMP environment and regulations.

Responsibilities

• Ensure compliance with regulatory commitments and company policies.
• Oversee production operations to assure PET drugs meet requirements.
• Review batch, laboratory and production records before batch release.
• Provide quality assurance oversight of production and shipping.

Skills

Analytical skills

Critical thinking

Customer service skills

Attention to detail

Project management

Education

BS/BA degree in relevant scientific discipline

Tools

Laboratory equipment

Job description

Job Title: Site Quality Assurance Manager (Site QA)

FLSA Status: Non-Exempt

Position Type: Full Time

Pay Type: Salary - Hourly

Pay Rate: $65,000.00 to 85,000.00 annually based on experience

Reports To: PET Facility Manager; dotted line to PharmaLogic PET Quality & Regulator

Job Posting Title: Quality Assurance Manager - On Site

Job Description

PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

Overview

PharmaLogic offers an exceptional opportunity to join our dynamic team as a Quality Assurance Manager. If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.

Responsibilities and Duties

• Ensure compliance with all regulatory commitments and company policies and SOPs, including cGMP and radiation safety.
• Actively promote adherence to SOPs, safety rules and awareness; report and take initiative to correct safety and environmental hazards.
• Provide immediate notification of quality related issues to site Manager, PET Operations Management and Q&R as necessary.
• Oversee production operations to assure that PET drugs meet requirements for identity, strength, quality and purity.
• May perform PET radiopharmaceutical Quality Control (QC) in a cGMP environment.
• May perform aseptic processing related tasks.
• Provide quality assurance oversight of routine production, packaging and shipping of radioisotopes.
• Examine and approve/reject components, closures, in-process materials, packaging materials, labeling and finished dosage forms to assure that all meet specification; manage onsite inventory quarantine and control processes according to SOPs.
• Ensure approved vendors are used and maintain documents and records, including COAs.
• Review batch, laboratory and production records to assure completeness, accuracy and conformance before batch release; authorize or reject batch according to SOPs or oversee batch release by other qualified team members.
• Perform batch trending analysis.
• Notify facility manager if any recall is necessary to assure that recalled materials are not administered to patients.
• Initiate changes to SOPs, participate in authoring and review, maintain documents under control in QMS, ensuring SOPs match processes and procedures in PET manufacturing operation.
• Document and trend deviations, IRs and events, initiate investigation and assure documentation of corrective actions and retraining as applicable.
• Initiate and complete CAPA investigations as required and report results and trends.
• Maintain facility compliance with environmental monitoring and aseptic control; review and trend environmental monitoring results and all testing records.
• Provide training to staff on QA activities and SOPs; assure staff is qualified for assigned quality tasks with documentation of training and qualification.
• Maintain records for inspection, perform annual retraining upkeep of training files.
• Assure aseptic processing of samples and products as per SOP; ensure processing area is properly cleaned, maintained, and controlled to prevent mix‑ups or contamination.
• Assure equipment is functional, calibrated, suitable for use, maintained and documented per SOP; maintain vendor IQ/OQ and site PQ documents.
• Maintain master production, laboratory controls/analytical tests and other control records consistent with actual work procedures; report discrepancies to PharmaLogic Quality and Regulatory.
• Maintain records to comply with FDA and SOP requirements; monitor and report on the location QA program to management.
• Lead site for FDA and other agency, vendor and internal quality audits; maintain audit readiness through thorough records, personnel, and facility review.
• Maintain site copy of ANDA and all related filing documentation; draft ANDA related documents for submission including annual reports and other updates as required.
• Conduct periodic and annual quality audits, training, SOP review and other activities as directed.

Job Requirements, Skills & Education

• BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 3‑5 years quality experience in the pharmaceutical industry, or an equivalent combination of education and experience.
• Pharmacy tech certification is a plus; experience with aseptic technique is a plus.
• Experience working with ionizing radiation and laboratory equipment is desirable, including troubleshooting and repairs.
• Strong analytical, critical thinking and customer service skills; experience working on a cross‑functional team in a fast‑paced environment.
• Strong knowledge of cGMP environment and regulations; knowledge of CFR21 Part 212 preferred.
• Strong attention to detail and experience managing multiple projects and priorities.

Benefits

• 401(k) retirement benefit program
• Medical
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Life insurance
• On‑site parking
• Paid time off
• Vision care

PharmaLogic offers a competitive compensation package and superior benefits.

PharmaLogic is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected class.