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Quality Specialist - II (Associate) Quality Specialist - II (Associate)

Company: LanceSoft Inc
Location: Wilson
Posted on: August 1, 2022

Job Description:

Job DescriptionThe responsibilities of the Specialist, Quality Assurance include, but are not limited to, the completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, defect resolution in packaging operations and control of material throughout the plant, plant investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, Supplier Quality Management and other Quality Assurance related functions as required. The Specialist, Quality Assurance is the primary source of advice, guidance and input regarding quality issues for production personnel and *** divisional and inter-site customers. The Specialist must demonstrate strong leadership capability and work independently to ensure job responsibilities are conducted in a timely and reliable manner to meet production demands. This position is knowledgeable in regulatory requirements, and ensures site compliance with all expectations. 1. **Batch record review and intermediate/finished product release activities for domestic distribution. 2. **Provides Quality Assurance review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status of Wilson operations. 3. **Defect resolution, including use of statistical methods, and control of material throughout the plant site. 4. **Participates in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition. 5. **Ownership and completion of Quality related investigations. 6. **Provides Quality oversight, strategy input, and concurrence on site level change controls (PCRs). Performs, interprets, reviews, and approves equipment/process validation/qualification activities. Provides review and approval of change control documents. Performs a variety of regulatory document reviews. Participates on PCR committee and sets Quality Operations requirements. 7. **Participates in project and PCR strategy meetings in support of Quality Master Data builds and maintenance 8. **Provides shift coverage support on as needed basis. 9. **Participates in the implementation of new programs/regulations/divisional processes at the site. 10. **Identifies continuous improvement (business and compliance excellence) opportunities and through collaboration and engagement with other functional groups, implements changes to processes. 11. **Maintains 5S organization and identifies improvement opportunities. 12. **Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents. Quals Must possess a B.A. /B.S. degree (preferably in Science or Engineering). Possesses an advanced knowledge and ability to operate information systems (SAP COMET and TrackWise preferred, IPI system) required to complete job responsibilities with the ability to generate data and reports from these systems. Must possess a minimum of minimum of three (3) years experience in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as: batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc. Must possess highly developed written and oral communication and teamwork skills. Additionally must have strong attention to detail, problem solving skills, and proficient in time management. Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures. Flexible, Multitasker, able to work under pressure and adheres to project timelines. Ability to independently respond to advances requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change. *Note: After completion of training / qualification and required accesses granted, there is a potential for flexibility in the work schedule allowing 1-2days / week of remote support.

Keywords: LanceSoft Inc, Wilson , Quality Specialist - II (Associate) Quality Specialist - II (Associate), Other , Wilson, North Carolina

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