QA Specialist II - TPM

Collins Consulting, Inc

North Chicago, IL

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Accidental Death and Dismemberment (AD&D), Biotech and Pharmaceutical, Change Management, Communication Skills, Consulting, Corrective Action, Cross-Functional, Document Management, Equipment Validation, Insurance, Manufacturing, Negotiation Skills, Process Validation, Product Development, Product Packaging, Product Strategy, Product Support, Project Tracking, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Risk, Risk Management, Small Molecules, Time Management

LOCATION

North Chicago, IL

POSTED

30+ days ago

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 clients 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

About the Company

Collins Consulting, Inc

Collins Consulting brings over two decades of total talent solutions experience to meet your on-demand consulting needs. We have an established history of serving clients nationwide in both the public and private industries. These clients range from Fortune 100 companies within the commercial arena to supporting contracts within federal agencies.

Collins Consulting is a certified Service-Disabled Veteran Owned Small Business and a SBA Small Business. We believe in servicing our country's veterans by supporting and nurturing opportunities to join their skillsets with clients who have the same principles. These certifications coupled with Top Secret facility clearance allow us to meet category and diversity goals.

Collins Consulting is agile, innovative, and an award winning advocate in providing total talent solutions to serve your business needs. Whether you are a professional who is looking for a new career or an organization in need of experienced talent, we have the resources to help you.

COMPANY SIZE

10 to 19 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

http://www.colcon.com