Quality Specialist

Full Time
Wilson, NC 27893
Posted
Job description

Responsibilities

  • Perform sampling, and inspection on incoming commercial and experimental/clinical raw materials, components, and intermediates.
  • Perform raw material component review to ensure correct quantities, labeling and visual appearance.
  • Oversee the administration of prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
  • Comprehend and adhere to all related SOPs, company policies, cGxPs, and regulatory requirements.
  • Comprehend and adhere to all pertinent Health and Safety regulations, policies and procedures and the required use of all approved and issued Personal Protective Equipment.
  • Execute activities/tasks (i.e., sampling, cleaning, packaging component testing.) in accordance with approved SOPs, schedules and communicates expected processing times for incoming raw materials, components, and intermediates to appropriate Warehousing, Planning, Operations, Pharm Tech, and Quality management. Efficient and proactive in executing assigned activities.
  • Maintain current training status and close all training gaps in a timely fashion.
  • Prepare and maintain tracking/testing systems, (i.e., LIMS, SAP, Logbooks, OCR, etc.) which are used for testing and to reflect status of samples. Reports status to appropriate laboratory, manufacturing and planning groups at pre-determined intervals.
  • Provide timely day-to-day decisions on compliance related issues in Production, Warehouse/Distribution, Facilities, Incoming QA, Quality Control and Stability areas based on expertise and collection of independently gathered information.
  • Assess accuracy and compliance of plant SOP’s as a SOP reviewer and approver and works with SOP author for timely approvals.
  • Communicate daily with supervision and others within work group as related to specific job function and demonstrate the ability to communicate with others outside of work group.
  • Demonstrate a level of consciousness to safety and health related activities as evident by the daily application of requirements specific to job function; Recognize safety and health related issues and report to supervision.
  • Support and maintain an environment that fosters communication and teamwork within Quality Assurance and related departments.
  • Perform other related assignments and duties as required and assigned.

Job Type: Contract

Schedule:

  • 8 hour shift
  • Overtime

Ability to commute/relocate:

  • Wilson, NC 27893: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • Manufacturing: 1 year (Preferred)

Shift availability:

  • Day Shift (Preferred)

Work Location: One location

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