Quality Specialist (2nd Shift) (Morris Plains)

Information about the Role:

• Position: QPIP Quality Person in Plant
• Location: Onsite in Morris Plains, NJ
• Shift: 2nd shift 2pm-11pm -- As most quality/manufacturing roles onsite, we need individuals to be somewhat flexible if issues occur that would cause someone to stay later. Additionally weekend work will rotate amongst the team. They have a great team culture, and they are looking to continue to foster that type of environment. So, they are only looking for individuals who have a passion for this space, allow flexibility, and are willing to roll up their sleeves/wear multiple hats within their team.
• $45-53/hr- Exact compensation may vary based on several factors, including skills, experience, and education.
• Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Qualifications:

• Bachelors degree with a concentration in engineering, science, or an equivalent technical discipline
• Minimum 5+ years of experience working within drug substance or pharma manufacturing space
• Minimum 4-6 years of experience working with analytical methods i.e. flow cytometry within QC manufacturing space
• Solid quality-centric experience and mindset (QA/QC) -Strong interpersonal skills both written and verbal
• Ability to quickly process complex information and make critical decisions with limited information in a complex and time-sensitive environment
• Experience in biologic or vaccine or cell culture products
• Previous experience working with or for CMOs is required

Day-to-Day: One of our large pharmaceutical clients is looking to hire a Quality Person In Plant to join the growing External Quality team within Advanced Therapeutics. This individual will be providing Quality oversight of the analytical space. Main responsibilities will include:

-Review and approve nonconformances and deviations out of specification.

-Interface as liaison internally and externally for review/approval/implementation of change controls.

-Support monitoring of EM quality performance and proactively identify risks.

-Influence and build relationship with internal and external partners to continuously enhance quality performance.

-Interface with other functions i.e. Operations, Planning, Technical Operations, etc. as well as the external manufacturer

-Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

-Provide on-site support as needed on request of the team lead