QC Team Lead

Minimum Requirements

· Bachelor degree in a Science subject.

· 3 years supervisory experience

· 7 years experience in a GMP or regulated production environment



Preferred Background

· Supervisory experience with demonstrated Leadership capabilities and responsibility.

· 7 years experience in the pharmaceutical industry, with at least 1 year within a laboratory or Quality Control environment/operation.

· Masters degree

· High level of knowledge and experience of QC/QA processes or systems (eg. Stability, laboratory investigations, LIMS management, HPLC, compendial changes, vendor certification, QA Systems, KPIs and metrics)

Major Responsibilities

· Participate in the development of the QC strategy, in conjunction with other key stakeholders. Execute the QC strategy including new projects, in accordance with company goals and direction. Lead and participate in projects, and other continuous improvement activities to drive performance and continuously align operation to business needs.

· Provide technical expertise and guidance for QC testing and systems.

· Ensure that all QC tests, including raw material and stability tests, are performed on time meeting all AZ and regulatory compliance standards, including those performed by for AZ by a contract laboratory.

· Ensure cGMP, SHE compliance and operational excellence within the team.

· Take lead role for QC in internal audits and regulatory inspections, including FDA (This will include the establishment and maintenance of subject matter experts capable of interacting with and presenting context and detailed knowledge, under pressure, on specific material relevant to the teams activities).

· Manage and develop capital and expense budgets for QC.

· Approve QC or process deviations, including laboratory investigations. Provide guidance on complex investigations. Ensure that team members are capable of actively contributing to investigations in other areas, such as PETs.

· Ensure that key customers and stakeholders, such as PETs and senior leadership are aware of key issues and opportunities. Provide timely and effective feedback to enable continuous improvement and learning.

· Use appropriate tools, such as Lean, six sigma, project management, and change management, to drive consistent ways of working, continuous improvements, and management of activities.

Category:	Information Technology
Location:	Wilmington, DE
County:	New Castle County
ZIP Code:	19801
Pay Rate:	Negotiable
Job Terms:	7-12 months (contract)
Company:	PSCI
Phone:	1302-334-4107
Fax:	email only