Sr Associate Scientist - Standards & Controls

Use Your Power for Purpose

The position will support the Pfizer Sanford, NC Quality Operations department by performing activities supporting standards & controls and continuous improvement projects.  At a minimum, the position should be able to execute work independently, work with various groups across the organization and be able to lead investigations utilizing operational excellence tools and techniques.  Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.  

The individual should be able to demonstrate the following:

• Acting safely, knows and follows all Environmental Health and Safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely.

• Recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting documentation management, reviewing content to ensure compliance to regulations and Pfizer policy and standards.

• Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines.

• Ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues.

• Applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals.

• Method 1, yellow belt trained and can apply tools to solve issues (including technical issues).

• Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development.

• Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail-oriented behavior.

• Good judgment and correct decision making based on Pfizer procedures, policy, and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network.

• Represents Quality Control on site and network teams/forums that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with team; acts as change agent for improvements.

• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule. 

• Delivery on high business impact projects/activities/changes. 

• Able to identify and seek out external resources to build or enhance understanding of documentation concepts/improvements and compliance; supports training of staff; mentoring and coaching junior colleagues.

What You Will Achieve

• Responsible for knowing, understanding, and acting in accordance with Pfizer’s values.

• Performs tasks associated with maintaining cGMP compliant process for QC.

• Perform documentation management for QC Labs and related areas, including:

• Tracking document requests.

• Assessment of document to current standards including current site document templates.

• Author support.

• Collaboration with Doc Control, Training, and QA to approve documents.

• Support regulatory audits, as required.

• Provide expertise for troubleshooting and resolution of issues related to business processes, equipment, facilities, utilities, and human performance.

• Assess potential impact of changes to qualified systems resulting from investigational CAPAs.
  Identify and implement documentation best practices to continuously improve the site performance.

• Represent QC on site or network teams as necessary.

• The position requires execution and management of multiple initiatives at the same time and good communication skills to keep customers, peers, and area management up to date with progress of all such efforts.
  Responsible for reporting issues to management and participating in issue resolution.

• Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.

• May initiate, manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.
  Trains junior colleagues a