QA Manager

4 weeks ago

Johnson City, United States PHARMALOGIC HOLDINGS Full time
Job DescriptionJob 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.


PharmaLogic offers you 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.

Position Title: QA Manager

Role Summary:

As the site Quality Assurance Manager, 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 site QA is responsible for training documentation for the staff on QA related activities.


The site QA is the responsible person for FDA inspections at the site and is listed on the FDA filing and associated permits as applicable. 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 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.

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