Position Title: Quality Assurance (QA) Operations Associate
Work Location: Millburn, NJ 07041
Assignment Duration: 12 Months
Work Schedule: Week 1: Sun-Wed AM (6:00am-5:30pm); Week 2: Sun-Tue AM (6:00am-6:30pm). Must be flexible with 36-42 hours per week.
Work Arrangement: Onsite

Position Summary: Our QA Operations Associate manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Quality Management Systems for the Millburn manufacturing site.

Background & Context: This role supports the manufacturing site by providing shopfloor quality oversight and ensuring compliance with GxP and data integrity standards for the organization.

Key Responsibilities:

·       Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity.

·       Ensure timely escalation to management of all applicable incidents.

·       Supports QA Operations programs especially related to batch release activities and shop floor programs which includes Visual Monitoring on Surprise (ViMOS), GEMBA walkthrough program, equipment/area/utility out of service program, QA area release of classified and unclassified areas, QA media fill oversight programs, event triage and support of routine operations.

·       Assist functional areas with achieving timely and compliant raw material disposition and ensure compliance of site personnel according to current procedures and GMP requirements

·       Oversight of Final Product dose storage once all manufacturing activities are completed.

·       Perform Facility Alarm review and assess the impact of each alarm. Escalate any GxP impact immediately

·       Perform live review of manufacturing/packaging batch records in preparation for batch release and escalate any discrepancies immediately.

·       Support FDA/Regulatory interactions for the Millburn RLT Site products to ensure successful regulatory submissions and inspections.

·       Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.

·       Support continuous quality improvement program for manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.

Qualification & Experience:

·       Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree.

·       2+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations

·       1+ years of experience in a quality assurance role preferred

·       Collaborating across boundaries

·       Functional Breadth

·       QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones

 

Working Conditions & Physical Demands:

·       Although the associate is considered a radiation worker, there is PPE that they are required to wear and worker has to wear safety gear, hard hats, also the personnel are required to wear PPE such as lab coat, hairnet, beardnet, coveralls, hood, booties.

·       They are gowned from head to toe in the production area which does require 2/3 hours of oversight a day.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 25.00/hr.