Quality Assurance Specialist III

The QA Specialist III will support clinical manufacturing operations. This individual will provide oversight of manufacturing activities from a quality perspective with limited supervision. The incumbent works cross-functionally with internal departments and external resources on QA related issues. The QA Specialist III supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• Oversight (with limited supervision) of clinical manufacturing activities (phase 1, phase 2 of APIs, ADCs), including area clearance, issuance, and review of batch records, and making decisions on initiation of deviations and investigations.
• Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities.
• Revision and/or review and approval of SOPs, Protocols, Reports, and Batch Records for continuous improvement.
• Support of Environmental Monitoring Program including Controlled Environments and Clean Utilities.
• Support and Participate in Self-Inspections, Internal and External Audits.
• Provide training and guidance to other departments on GMP, Data Integrity and general Compliance aspects.
• Provide oversight on Event Reports, including Deviations and Investigations, and follow up to closure.
• Perform Document Control Tasks, on paper and electronic documents; including issuance of logbooks.
• Support of implementation of CAPA as determined.
• Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods.
• Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
• Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
• Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators. This task will occasionally require overnight and/or weekend work.
• Support Quality Management Systems (i.e. Master Control) in both performing QA tasks using these systems (document control, procedure review/approval, supplier qualification, etc.) and also in managing such systems.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities:

• Able to handle multiple client projects for Quality requirements.
• Ability to write and present reports/investigations and host meetings to support Quality Systems
• Ability to train employees in a small group setting.
• Experience with Master Control (electronic documentation system) or similar QMS (ie. 1QEM) is preferable.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Education and Experience Requirements:

• 2-4 years QA experience in Biotech/Pharma industry or combination of QA/MFG or QC experience or in GMP environment. Level at hire will be based on years of experience.
• Working knowledge of GMPs and their application to biotech/pharma/phase 1 and 2 clinical manufacturing
• Strong compliance knowledge of GMP Quality Systems, policies, and regulations
• Must be able to interpret applicable GMP standards and objectively decide on items with management support.

Physical Demands:

Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

Working Conditions:

Office/ Laboratory position

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.