2 QA Manager Jobs in Bronx, NY
PharmaLogic Holdings Corp. is Hiring a QA Manager Near Bronx, NY
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 ManagerRole 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.
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
Job Requirements │ Skills │Education:BS/BA degree in a relevant scientific discipline (chemistry, physics, nuclear pharmacy, nuclear medicine, engineering, etc.) and a minimum of 3-5 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.
BenefitsPharmaLogic 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, 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 Summary
Contractor
$133k-168k (estimate)
06/23/2024
08/15/2024
The job skills required for QA Manager include Quality Assurance, Quality Control, Initiative, Calibration, SOP, Commitment, etc. Having related job skills and expertise will give you an advantage when applying to be a QA Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QA Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for QA Manager positions, which can be used as a reference in future career path planning. As a QA Manager, it can be promoted into senior positions as a Quality Assurance Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Manager. You can explore the career advancement for a QA Manager below and select your interested title to get hiring information.
If you are interested in becoming a QA Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a QA Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on QA Manager job description and responsibilities
A quality assurance manager ensures that a product meets the required qualifications to become acceptable.
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Quality assurance managers set basic ground rules such as what testing tools should be use, which methodologies they should apply, and on how to define defect status.
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Establish measurable and reportable criteria for success.
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Evaluate the project when complete.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on QA Manager jobs
Try to spot possible regression as early as possible.
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Recognize different perspectives.
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Select team members and assign responsibilities carefully.
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You should spend time with team members and provide an honest feedback so they can know the areas that they need to improve.
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