Quality Specialist II

Quality Specialist

Pay Rate: $45/HR Location: 4633 Client Road, Wilson, NC 27893

Qualifications:

Education: Must possess a B.A./B.S. degree (preferably in Science or Engineering).

Required experience and skills:

• Possesses an advanced knowledge and ability to operate information systems (SAP and Veeva Systems preferred) required to complete job responsibilities with the ability to generate data and reports from these systems.
• Must possess a 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 advance requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.

Responsibilities:

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.

This position is knowledgeable in regulatory requirements and ensures site compliance with all expectations.

1. Retrieval and tracking of site Batch Records including, but not limited to, retrieval from Operations, archiving into the appropriate tracking system, scanning for Canadian market, and filing in applicable Document Retention room.
2. Tracking, retrieval, storage (including shipping offsite), execution of retrieval challenges, and destruction of batch records beyond retention period as applicable.
3. Ensure proper allocation of Document Retention room capacity.
4. Assist with the reconciliation of High/Medium controlled print documents.
5. Retrieve, prepare, and provide Certificate of Compliance (CoC) for the finished goods batches as requested. Additionally, support retrieval, preparation, and submission of requested Certificate of Analysis (CoA) for associated bulk drug product batches associated with the requested finished goods batches.
6. Support the tracking and processing of Registered Country Table (RCT) tender request forms regarding allocation of material / batches within SAP system for markets beyond the designated marketing location.

Additional Responsibilities may include the following:

• 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 and through collaboration and engagement with other functional groups, implements changes to processes.
• Maintains 5S organization and identifies improvement opportunities.
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.

Comments/Special Instructions:

Looking for a contractor in a quality group. Individual will be shared resource between 2 departments. 1 department performs the batch disposition, change control, deviation and shop floor management and the other does the compliance related work like APR, documentation, change control approvals, quality oversight.

Day to day:

• Reconciling the documents
• Help with archiving documents
• Retention of documents
• To assist with forms
• Manager shared box emails