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.
PharmaLogic offers you an exceptional opportunity to join our dynamic team as an On-Site QA Specialist!
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 completion of required quality assurance tasks of finished drug product as directed by cGMP SOPs and serves as site expert on PET quality assurance. The position involves a hands-on role in all quality assurance duties for the site, including materials acceptance and quarantine, batch release & record review, drug quality control, sterility, environmental monitoring, equipment maintenance / qualification/ calibration, investigation (IR, OOS, deviation, etc.) and corrective actions (CAPA), SOP writing, maintenance and review, inspection readiness, data quality and integrity, ANDA documentation and other routine QA functions.
The QA Specialist is responsible for assisting in FDA inspections at the site. Ideally, there will be separation of QA functions from production and QC functions. However, depending on the size of the facility, these activities may be performed by the same person if there is the ability to segregate batch release from production through appropriate cross-training for batch release. For smaller facilities, the site QA Specialist may assume other duties which may include production activities, operation of the facility's cyclotron and associated chemistry modules and analytical equipment for production and QC of PET radiopharmaceuticals. The position may be required to perform various radiation safety and quality related tasks as directed by management.
Job Responsibilities and Duties:
Ensure compliance with all regulatory commitments and company policies and SOPs including cGMP and radiation safety.
Actively promote adherence to SOPs, as well as safety rules and awareness. Report and take initiative to 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 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 specification; manage onsite inventory quarantine and control process according to SOPs to assure specifications are met.
Assure approved vendors 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 necessary to assure that recalled materials are not administered to patients.
Initiate change 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 investigation 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 suitably cleaned, maintained, controlled to prevent mix-ups or contamination; assure personnel qualified in aseptic technique and cleaning of the area and that approved cleaning agents and processes 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. Assure equipment qualified and operated under specified conditions; 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 reported to PharmaLogic Quality and Regulatory.
Assist in maintaining records to comply with FDA and SOP requirements. Maintain, monitor, and report out 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.
Assists in conducting 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 1-3 years Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience preferred. Pharmacy tech 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 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.
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, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
Benefits Include:
401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Life insurance
On-site parking
Paid time off
Vision care
Job Title: Pharmaceutical Production Technician
Pay Rate: $23.00 to 24.00/hour
Reports To: PET Facility Manager
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.
PharmaLogic offers you an exceptional opportunity to join our dynamic team as a Pharmaceutical Production Technician!
The hours are 11pm to 7am. 40 hours per week.
$23.00 to $24.00/hour + Benefits
Job Overview:
As a Pharmaceutical Production Technician at PharmaLogic, you will play a vital role in the production and QC of PET radiopharmaceuticals in compliance with applicable safety, quality, and regulatory requirements. The position involves maintenance and repairs of some equipment such as chemistry modules and analytical equipment. You will be expected to assist in facility maintenance, system repairs, PMs, and system modifications to increase your expertise and ensure system reliability.
Job Responsibilities and Duties:
Operate cyclotron for PET production.Perform maintenance and repairs on synthesis modules and analytical equipment.Perform PET radiopharmaceutical production and Quality Control (QC) in cGMP environment. Responsible for routine production, packaging and shipping of radioisotopes.Ensure compliance with all regulatory commitments and company policies and procedures including cGMP and radiation safety.Maintain records to comply with FDA requirements.Order parts and supplies for maintenance and production.Clean and maintain production areas (hot cells, laminar flow hoods, etc.).Other related duties as assigned.Job Requirements │ Skills │ Education:
Academic background in physics, chemistry, engineering, or electronic technology; or completion of training at an advanced military electronics school; or an equivalent combination of education and experience.Experience in electrical, mechanical engineering, Physics, medical equipment services or equivalent. Pharmacy tech certification a plus.Experience working with ionizing radiation and radioactive equipment.Experience troubleshooting, performing repairs and maintaining equipment.Strong analytical, troubleshooting and customer service skills.Working knowledge of cGMP environment and regulations.
Physical and Intellectual Requirements:
Manual dexterity for manipulating small items; regularly lift at least 50 pounds throughout each shift and to be able to lift 75 pounds on occasion. Able to handle standing, walking and sitting for 4+ hours with limited rest intervals; good eye-hand coordination; fair eyesight (with or without correction lenses); normal hearing in at least one ear (hearing range of 20 Hz to 20 kHz); ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.
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, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
Benefits Include:
401(k) retirement benefit program
Medical
Dental care
Disability insurance
Employee assistance program
Extended health care
Life insurance
Paid time off
Vision care
