PharmaLogic
Quality Assurance Specialist
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.
Job Overview As the Quality Assurance Specialist, you will play a vital role in the PharmaLogic quality program to assure compliance with cGMP and other standards for the manufacture of drugs for administration to patients. Responsible for completing required QA tasks of finished drug product as directed by cGMP SOPs and serves as site expert on PET QA. The position involves a hands‑on role in all quality assurance duties for the site, including materials acceptance, batch release, drug quality control, sterility, environmental monitoring, equipment maintenance, calibration, investigations (IR, OOS, deviation, etc.) and corrective actions (CAPA). You will also assist in FDA inspections and maintain routine QA functions such as SOP writing, inspection readiness, data integrity, ANDA documentation, and other routine QA functions.
Job Responsibilities
Ensure compliance with all regulatory commitments and company policies and SOPs, including cGMP and radiation safety.
Actively promote adherence to SOPs and safety rules; report and correct safety & 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.
Responsible for 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 specifications; manage onsite inventory quarantine and control processes according to SOPs.
Assure approved vendors are used and maintain documents and records, including COA.
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 of SOPs, maintain documents under control in QMS.
Assure SOPs match processes and procedures in PET manufacturing operation and report concerns to Management.
Document and trend deviations, IRs, events and initiate investigation and assure documentation of corrective actions and retraining as applicable.
Initiate and complete CAPA investigations as deemed necessary, and report results and trends.
Maintain facility compliance with environmental monitoring and aseptic control; review and trend environmental monitoring results and all testing records.
Maintain records for inspection; perform annual retraining upkeep of training files.
Assure aseptic processing of samples and products as per SOP; assure aseptic processing area is suitably cleaned, maintained, and controlled to prevent mix-ups or contamination; assure personnel are qualified in aseptic technique and cleaning of the area and that approved cleaning agents and processes are used according to SOP.
Assure environmental monitoring records are complete and readily available, including annual personnel media fill qualifications.
Assure equipment is functional, within calibration, suitable for use, maintained, and documented per SOP; maintain vendor IQ/OQ and site PQ documents.
Assure master production, laboratory controls/analytical tests and other control records are consistent with actual work procedures and any discrepancies are reported to PharmaLogic Quality and Regulatory.
Assist in maintaining records to comply with FDA and SOP requirements; maintain, monitor, and report on the location QA program to management.
Support the site lead for FDA and other agency, vendor and internal quality audits, as directed; maintain site audit readiness by thorough records, personnel, and facility review.
Maintain site copy of ANDA and all related filing documentation up to date, available and organized for review; draft ANDA related documents for submission including annual reports and other updates as required.
Assist in conducting periodic and annual quality audits, training, SOP review and other activities as directed.
Job Requirements
BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 1–3 years of Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience.
Pharmacy technician certification a plus; experience with aseptic technique a plus.
Experience working with ionizing radiation and laboratory equipment 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 with managing multiple projects and priorities.
Benefits
401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Life insurance
On‑site parking
Paid time off
Vision care
Employment Details
Seniority level: Entry level
Employment type: Contract
Job function: Quality Assurance
Industry: Pharmaceutical Manufacturing
Base pay range:
$50,000.00/yr – $60,000.00/yr
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.
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Job Overview As the Quality Assurance Specialist, you will play a vital role in the PharmaLogic quality program to assure compliance with cGMP and other standards for the manufacture of drugs for administration to patients. Responsible for completing required QA tasks of finished drug product as directed by cGMP SOPs and serves as site expert on PET QA. The position involves a hands‑on role in all quality assurance duties for the site, including materials acceptance, batch release, drug quality control, sterility, environmental monitoring, equipment maintenance, calibration, investigations (IR, OOS, deviation, etc.) and corrective actions (CAPA). You will also assist in FDA inspections and maintain routine QA functions such as SOP writing, inspection readiness, data integrity, ANDA documentation, and other routine QA functions.
Job Responsibilities
Ensure compliance with all regulatory commitments and company policies and SOPs, including cGMP and radiation safety.
Actively promote adherence to SOPs and safety rules; report and correct safety & 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.
Responsible for 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 specifications; manage onsite inventory quarantine and control processes according to SOPs.
Assure approved vendors are used and maintain documents and records, including COA.
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 of SOPs, maintain documents under control in QMS.
Assure SOPs match processes and procedures in PET manufacturing operation and report concerns to Management.
Document and trend deviations, IRs, events and initiate investigation and assure documentation of corrective actions and retraining as applicable.
Initiate and complete CAPA investigations as deemed necessary, and report results and trends.
Maintain facility compliance with environmental monitoring and aseptic control; review and trend environmental monitoring results and all testing records.
Maintain records for inspection; perform annual retraining upkeep of training files.
Assure aseptic processing of samples and products as per SOP; assure aseptic processing area is suitably cleaned, maintained, and controlled to prevent mix-ups or contamination; assure personnel are qualified in aseptic technique and cleaning of the area and that approved cleaning agents and processes are used according to SOP.
Assure environmental monitoring records are complete and readily available, including annual personnel media fill qualifications.
Assure equipment is functional, within calibration, suitable for use, maintained, and documented per SOP; maintain vendor IQ/OQ and site PQ documents.
Assure master production, laboratory controls/analytical tests and other control records are consistent with actual work procedures and any discrepancies are reported to PharmaLogic Quality and Regulatory.
Assist in maintaining records to comply with FDA and SOP requirements; maintain, monitor, and report on the location QA program to management.
Support the site lead for FDA and other agency, vendor and internal quality audits, as directed; maintain site audit readiness by thorough records, personnel, and facility review.
Maintain site copy of ANDA and all related filing documentation up to date, available and organized for review; draft ANDA related documents for submission including annual reports and other updates as required.
Assist in conducting periodic and annual quality audits, training, SOP review and other activities as directed.
Job Requirements
BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 1–3 years of Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience.
Pharmacy technician certification a plus; experience with aseptic technique a plus.
Experience working with ionizing radiation and laboratory equipment 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 with managing multiple projects and priorities.
Benefits
401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Life insurance
On‑site parking
Paid time off
Vision care
Employment Details
Seniority level: Entry level
Employment type: Contract
Job function: Quality Assurance
Industry: Pharmaceutical Manufacturing
Base pay range:
$50,000.00/yr – $60,000.00/yr
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.
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