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Date Added: Thu 05/05/2022

Quality Specialist - II (Associate)

Durham, NC, US
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Company: ACS SOLUTIONS

Job Type: Permanent, FullTime

JOB DESCRIPTION

Job Title: Quality Specialist (Associate)

Location: 5325 Old Oxford Road, Durham, NC

Duration: 18 months contract

Pay range: $40 - $45/hr on W2

Shift Information

  • Required/Mandatory OT
  • Shift:- 24/7 Shop with 12-hour shifts. 1st Shift is 6:00 AM to 6:30 PM and 2nd Shift is 6:00 PM to 6:30 AM - Initially the positions filled will work first shift.
  • There is a 2-2 3-2 2-3 Rotating Shift Schedule in place - It consists of a 4-week cycle where designated Second Shift team works, 2 consecutive day shifts, followed by 2 days off duty, works 3 consecutive day shifts, followed by 2 days off duty, works 2 consecutive day shifts, followed by 3 days off duty.
  • Personnel work an average 42 hours per week.

Required Experience and Skills

  • Bachelor's degree in a scientific or engineering field (biologics or pharma preferred); candidates with other degrees in other fields will be considered if accompanied by significant relevant experience.
  • Experience vs. degree, however a college education/degree is required.
  • Minimum two years of relevant post-degree work in a laboratory, manufacturing, quality position
  • Other GMP regulated industries okay.
  • Excellent written, verbal and interpersonal communication skills
  • Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing
  • Familiarity with GMP documentation review is a key skill necessary for success in this role
  • Problem-solving skills
  • Evidence of leadership skills coupled with good verbal and written communication skills
  • Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area

Preferred Experience and Skills

  • Experience working in a clean room/non-sterile environment
  • Experience working, collaborating and communicating across cross-functional teams (i.e., quality, operations, productions)
  • Experience working in large teams; resourcefulness in finding the right person for help
  • Familiarity with SAP, TrackWise and VeevaVault Quality Docs experience preferred

About you -

  • You are a forward-thinking, self-driven problem-solver!!
  • Your keen attention to detail and organization helps you stay on track and manage to strict deadlines without sacrificing quality.
  • You communicate extremely well and have no problem coming out of your shell! You motivate and inspire others to collaborate and share their ideas as well.
  • You thrive with in-person interaction and love working as part of a large production team!
  • You are a very well trained and efficient worker. You know your role and you do it very well. You are always excited to help others and provide a leadership approach to your work.

Responsibilities:

  • The Quality Specialist (Quality Specialist-II) is responsible for all Quality related functions that directly support Durham within the CDS2 Facility (COVID Drug Substance Vaccine Manufacturing) IPT (Integrated Product Team) while actively participating in and embracing an empowered team culture.
  • The Quality Specialist, with guidance from the IPT Quality Leader is responsible for the following tasks:
  • Ensures product/process quality, represents Quality on the shop floor, ensures adherence to Good Manufacturing and Documentation Practices
  • Completes quality checks and SAP transactions required to support release of product.
  • The Quality Specialist performs 100% process document/logbook audits for accuracy and completeness and works closely with IPT in a team environment to ensure timely review and documentation is Right First Time (RFT).
  • Provides support directly to the production floor, to include oversight for adherence to cGMPs, RFT completion of production GMP documentation, environmental monitoring (EM) matters, review and classification of atypical events including assessing product impact for EM events, providing Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, along with review and approval of Quality related SOP's and providing support for effective investigation of deviations.
  • Spends significant time on the shop floor collaborating with Operations and Technology to enable RFT production, to learn the manufacturing process, and to ensure compliance with cGMPs and regulatory requirements
  • The Quality Specialist is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance, and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the IPT
  • The Quality Specialist performs 75% of job functions on the production shop floor in a team environment
  • Partnering with operations, conducting reviewing, documenting cleaning logs and performing logbook audits, ensuring areas are sanitized, responding to environmental monitoring alarms, etc.

Primary Responsibilities

  • Quality batch record review and approval (including associated autoclave records, filter integrity testing results, and supplemental reports)
  • Quality review for per process environmental monitoring
  • Partners with Planning, Operations and Technology organizations to ensure batches are ready for release and shipment by appropriate due dates
  • Quality review and approval of new and updated SOPs and Controlled Job Aids
  • GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements
  • Assists with training of incoming personnel and ensures compliance with departmental procedures
  • Actively participates in the Tier process and uses this forum to escalate concerns and best practices
  • Works with IPT members in the identification and implementation of continuous improvement initiatives and action plans
  • Provide Quality oversight to alarm events (non-viable particles, differential pressure, temperature, and humidity) during processing
  • Review incursions into classified areas for process and environmental impact and approve accordingly
  • Review and classification of atypical events including assessing product impact for EM events.
  • Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations
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