PharmaLogic ยท 1 day ago
Quality Assurance Manager - On Site
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
$65K/yr - $90K/yr
3+ years expPharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization. They are seeking a Quality Assurance Manager to ensure compliance with cGMP standards and oversee quality assurance tasks related to the manufacture of drugs for patient administration.
Pharmaceuticals
Responsibilities
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
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. 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
Maintain records to comply with FDA and SOP requirements. Maintain, monitor, and report out on the location QA program to management
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
Conduct periodic and annual quality audits, training, SOP review and other activities as directed
Qualification
Required
BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.)
Minimum of 3-5 years Quality experience in the pharmaceutical industry, or an equivalent combination of education and experience
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
Strong attention to detail and experience with managing multiple projects and priorities
Preferred
Pharmacy tech certification
Experience with aseptic technique
Experience working with ionizing radiation and laboratory equipment
Knowledge of CFR21 Part 212
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
Company
PharmaLogic
PharmaLogic is a leading global contract development and manufacturing organization (CDMO) specialized in diagnostic and therapeutic radiopharmaceuticals.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Keith Kennedy
Chief Financial Officer
Deborah Vanerka
Chief Revenue Officer (CRO)
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