QA Specialist II, QA Production Support (8pm-6:30a

2/5/24

Raleigh, NC

2235

FullTimeRegular

The Quality Assurance (QA) Specialist II, QA Production Support is a position on the Hybrid Shift reporting to the Senior QA Specialist I. The candidate must demonstrate thorough understanding, knowledge and ability in primary discipline. The QA Specialist II, QA Production Support is responsible for performing incoming sampling of materials, support room /line clearances and provide QA input into production event resolution to assure that quality operations are in conformance to GMP requirements. Also responsible for identifying compliance deficiencies, providing QA SME input into investigations as required and assisting with the resolution plan.

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 the 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, Webscan, RFID Scanner, 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.
  • Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
  • Performs other related assignments and duties as required and assigned.

Education and Experience

  • BS required
  • 2 years minimum relevant experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS Preferred) with one-year minimum experience.

Necessary Knowledge, Skills, and Abilities

  • Basic understanding of applicable regulatory requirements as it relates to job function demonstrated by adherence to policies and procedures
  • Basic ability to perform computer transactions related to job functions demonstrated by right first-time measures
  • Ability to perform job function using appropriate instrumentation and applicable techniques demonstrated by efficient and accurate completion of work
  • Ability to applies technical knowledge and experience in performing job functions as is displayed through independence in daily performance of work
  • Ability to apply and evaluate systems and procedures for improvement opportunities demonstrated through discussion of recommendations with supervision
  • Ability to overcome obstacles to achieve results as indicated by ability to resolve issues and meet timelines
  • Demonstrate application of industry best practices and specific regulatory requirements for evaluation of systems and procedures for improvement opportunities and communicates results and ideas to supervision on a regular basis.
  • Ability to troubleshoot and recommend improved methods or techniques of performing job function or utilizing instrumentation demonstrated by ability to achieve results, gain right first-time output, and improve efficiency
  • Ability to utilize multiple IT systems required for job performance and utilize reports for analysis demonstrated by consistent right first time results and independent resolution of issues
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