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PharmaLogic is a rapidly growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) focused on delivering transformative diagnostic and therapeutic agents to patients worldwide.
Position Title QA Manager
Role Summary The QA Manager will play a pivotal role in ensuring compliance with cGMP and other regulatory standards for the manufacture of PET radiopharmaceuticals. Responsibilities include overseeing quality assurance tasks for finished drug products, serving as the site expert on PET QA, and supporting FDA inspections. The position may also involve supporting production and QC activities in smaller facilities, as well as radiation safety and other quality-related tasks directed by management.
Job Responsibilities and Duties
Ensure compliance with all regulatory commitments, company policies and SOPs, including cGMP and radiation safety.
Promote adherence to SOPs, safety rules and awareness; report and correct safety & environmental hazards.
Notify site manager, PET operations management and Q&R of quality issues.
Oversee production operations to ensure PET drugs meet strength, quality and purity requirements.
Perform PET radiopharmaceutical QC in a cGMP environment (as required).
Perform aseptic processing related tasks (as required).
Oversee routine production, packaging and shipping of radioisotopes.
Examine and approve/reject components, closures, in-process materials, packaging materials, labeling and finished dosage forms; manage onsite inventory quarantine per SOPs.
Maintain approved vendor documentation and records, including COAs.
Review batch, laboratory and production records for completeness, accuracy and conformance before batch release; authorize or reject batch per SOPs.
Perform batch trending analysis.
Notify facility manager of recalls to prevent material administration to patients.
Initiate SOP changes, author SOPs, and maintain documentation control in QMS.
Document and trend deviations, IRs, events; investigate and document corrective actions and retraining.
Initiate and complete CAPA investigations and report results and trends.
Maintain environmental monitoring compliance, review and trend monitoring results and testing records.
Provide QA training to staff on SOPs; maintain staff qualifications and training files.
Maintain records for inspection; perform annual retraining upkeep.
Ensure aseptic processing areas are clean, controlled, and personnel are qualified.
Maintain equipment calibration, qualification, and operation per SOP; manage vendor IQ/OQ and site PQ documents.
Maintain master production, laboratory controls and analytical test consistency; report discrepancies to Quality and Regulatory.
Maintain FDA and SOP compliance records; report QA program status to management.
Lead FDA and other audits; maintain audit readiness.
Maintain site copy of ANDA and related filing documents; draft ANDA submissions and updates.
Conduct periodic and annual quality audits, training, SOP review and related activities.
Job Requirements, Skills & Education
BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and 3-5 years of quality experience in the pharmaceutical industry, or equivalent education/experience.
Pharmacy technician certification a plus; experience with aseptic technique a plus.
Experience working with ionizing radiation and laboratory equipment, including troubleshooting and repairs.
Strong analytical, critical thinking and customer service skills.
Experience working cross‑functionally in a fast‑paced environment.
Strong knowledge of cGMP environment and regulations; knowledge of CFR21 Part 212.
Strong attention to detail and experience managing multiple projects and priorities.
Benefits Include
401(k) retirement benefit program
Medical coverage
Dental care
Life insurance
Employee assistance program
On‑site parking
Paid time off
Vision care
PharmaLogic offers a competitive compensation package and superior benefits. Come join our winning team and begin a fulfilling career with us by applying today.
PharmaLogic is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, or veteran status.
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Position Title QA Manager
Role Summary The QA Manager will play a pivotal role in ensuring compliance with cGMP and other regulatory standards for the manufacture of PET radiopharmaceuticals. Responsibilities include overseeing quality assurance tasks for finished drug products, serving as the site expert on PET QA, and supporting FDA inspections. The position may also involve supporting production and QC activities in smaller facilities, as well as radiation safety and other quality-related tasks directed by management.
Job Responsibilities and Duties
Ensure compliance with all regulatory commitments, company policies and SOPs, including cGMP and radiation safety.
Promote adherence to SOPs, safety rules and awareness; report and correct safety & environmental hazards.
Notify site manager, PET operations management and Q&R of quality issues.
Oversee production operations to ensure PET drugs meet strength, quality and purity requirements.
Perform PET radiopharmaceutical QC in a cGMP environment (as required).
Perform aseptic processing related tasks (as required).
Oversee routine production, packaging and shipping of radioisotopes.
Examine and approve/reject components, closures, in-process materials, packaging materials, labeling and finished dosage forms; manage onsite inventory quarantine per SOPs.
Maintain approved vendor documentation and records, including COAs.
Review batch, laboratory and production records for completeness, accuracy and conformance before batch release; authorize or reject batch per SOPs.
Perform batch trending analysis.
Notify facility manager of recalls to prevent material administration to patients.
Initiate SOP changes, author SOPs, and maintain documentation control in QMS.
Document and trend deviations, IRs, events; investigate and document corrective actions and retraining.
Initiate and complete CAPA investigations and report results and trends.
Maintain environmental monitoring compliance, review and trend monitoring results and testing records.
Provide QA training to staff on SOPs; maintain staff qualifications and training files.
Maintain records for inspection; perform annual retraining upkeep.
Ensure aseptic processing areas are clean, controlled, and personnel are qualified.
Maintain equipment calibration, qualification, and operation per SOP; manage vendor IQ/OQ and site PQ documents.
Maintain master production, laboratory controls and analytical test consistency; report discrepancies to Quality and Regulatory.
Maintain FDA and SOP compliance records; report QA program status to management.
Lead FDA and other audits; maintain audit readiness.
Maintain site copy of ANDA and related filing documents; draft ANDA submissions and updates.
Conduct periodic and annual quality audits, training, SOP review and related activities.
Job Requirements, Skills & Education
BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and 3-5 years of quality experience in the pharmaceutical industry, or equivalent education/experience.
Pharmacy technician certification a plus; experience with aseptic technique a plus.
Experience working with ionizing radiation and laboratory equipment, including troubleshooting and repairs.
Strong analytical, critical thinking and customer service skills.
Experience working cross‑functionally in a fast‑paced environment.
Strong knowledge of cGMP environment and regulations; knowledge of CFR21 Part 212.
Strong attention to detail and experience managing multiple projects and priorities.
Benefits Include
401(k) retirement benefit program
Medical coverage
Dental care
Life insurance
Employee assistance program
On‑site parking
Paid time off
Vision care
PharmaLogic offers a competitive compensation package and superior benefits. Come join our winning team and begin a fulfilling career with us by applying today.
PharmaLogic is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, or veteran status.
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