Job Details

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 (Relocation assistance will be offered)

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 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:

Maintain oversight of the QA program and Quality Management System (QMS) at a single manufacturing facility producing products under 21 CFR Part 211 regulations.

Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.

Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.

Write, review, approve, and implement procedures, specifications, processes, and methods as required.

Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.

Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.

Ensure that personnel are properly trained and qualified. Ensure that the training is documented.

Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.

Liaise with internal and external inspectors and representatives, particularly on QA-related topics.

Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).

Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that require correction.

Review documents associated with the site's QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.

Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.

Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.

Ensure any deviations from normal procedures are documented and justified.

Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).

Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 211 requirements.

Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations.

Attend quality and operational meetings. Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management.

Expected extensive knowledge of at least one product.

Qualifications:

Associate or Bachelor's Degree, at minimum

Relevant certifications and/or experience may be substituted in lieu of this requirement

CGMP: 5 years (Preferred)

Management: 3 years (Preferred)

Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.

Quality, Pharmacy, or CGMP manufacturing experience preferred.

Knowledge of USP, FDA, and cGMP regulations preferred.

Knowledge of how and ability to write, review, and revise SOPs required.

Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.

Ability to write reports, business correspondence, and procedure manuals required.

Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the general public required.

Ability to define problems, collect data, establish facts, and draw valid conclusions required.

Ability to solve problems and handle issues required.

Proficient in MS Office applications required.

Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.

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