Job Description

The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the support of batch record management, retrieval and generation of batch conformance documentation (CoC and CoA), completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, support site Quality owned 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 must demonstrate strong leadership capability, critical thinking skills, and the ability to work independently to ensure job responsibilities are conducted in a timely and reliable manner to meet production demands.

Responsibilities

• Support of batch record management
• Retrieval and generation of batch conformance documentation (CoC and CoA)
• Completion of batch record reviews for domestic market
• Intermediate and finished product releases for domestic market
• Support site Quality owned investigations
• Data compilation/support for internal/external audits and regulatory inspections
• SOP development and review
• Supplier Quality Management
• Other Quality Assurance related functions as required
• Retrieval and tracking of site Batch Records
• Tracking, retrieval, storage, execution of retrieval challenges, and destruction of batch records beyond retention period
• Assist with the reconciliation of High/Medium controlled print documents
• Retrieve, prepare, and provide Certificate of Compliance (CoC) for the finished goods batches as requested
• Support retrieval, preparation, and submission of requested Certificate of Analysis (CoA)
• Support the tracking and processing of Registered Country Table (RCT) tender request forms
• Batch record review and intermediate/finished product release activities for domestic distribution
• Provides Quality Assurance review and approval of GMP-related SOPs
• Assist in the development of procedures to improve compliance status of Wilson operations
• Defect resolution, including use of statistical methods, and control of material throughout the plant site
• Participates in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition
• Ownership and completion of Quality related investigations
• Participates in project and PCR strategy meetings in support of Quality Master Data builds and maintenance
• Participates in the implementation of new programs/regulations/divisional processes at the site
• Identifies continuous improvement (business and compliance excellence) opportunities
• Maintains 5S organization and identifies improvement opportunities
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents

Qualifications

• Must possess a B.A. /B.S. degree (preferably in Science or Engineering)
• Must possess a minimum of three (3) years’ experience in a GMP pharmaceutical manufacturing facility

Required Skills

• Possesses an advanced knowledge and ability to operate information systems (SAP and Veeva Systems preferred)
• Must possess highly developed written and oral communication and teamwork skills
• Strong attention to detail, problem solving skills, and proficient in time management
• Identifies and solves a range of problems in straightforward situations
• 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

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