QA Specialist II - TPM

This is a hybrid position. Looking for local candidates only.

Responsible for managing the quality oversight of assigned small molecule pharmaceutical products manufactured at external partners, to ensure business objectives are met with regards to on time delivery of products while assuring compliance with the client policies and standards, as well as external agency regulations. Develops in concert with the cross functional team, the appropriate strategies for product transfers.

Responsibilities

• Management oversight for project activities at TPMs to achieve on-time quality deliverables. Driver for the quality and compliance aspects of product packaging transfers.
• Participates in the development of global Product Quality Assurance strategies to support pharmaceutical products produced at third party manufacturing (TPM) facilities. Implements agreed strategies.
• Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for pharmaceutical products and elevates medium and high-risk events to the client's management.
• Establishes and maintains relationships and open communication with Third Party Manufacturers, affiliates and other functional groups to maintain roles and responsibilities.
• Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks.
• Provides support for quality audits. Supports pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
• Supports the management of exception documents and Corrective and Preventive Actions.
• Manages change plans tasks related to packaging process transfers to ensure timely and compliant execution, including but not limited to QTA updates, specification and Master Batch records setting, equipment qualification reviews, process validation approval, timely stability initiation...
• Support Audits
• Review and approve TPM PQRs and/or APRs
• Lead/Contribute to investigations at TPMs
• Support packaging transfer projects and activities at TPMs

What are the top 3-5 skills, experience or education required for this position:
1. Equipment Engineering
2. Validation / Qualification
3. Manufacturing
4. Packaging experience a plus

The benefits that you are eligible for with Collins Consulting, Inc:

• 401(k)
• Medical, Dental and Vision Insurance
• Term Life Insurance
• Accidental Death and Dismemberment
• Long Term Disability