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 disciplines 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 Pfizers 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 and may develop training plans and/or oversee training activities.

• Responsible for assessing existing QC situations and suggesting continuous improvements to increase compliance and innovation.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with at least 3 years of experience; OR a masters degree with 0 years of experience.

• Manufacturing quality or engineering experience in the biotech or pharmaceutical industry.

• Understanding of cGMP and Safety regulations.

• Strong organizational and communication skills.

• Team based collaborative problem solving.

• Strong understanding of cGMP Data Integrity and ALCOA principles.

• Experience with project management.

Physical/Mental Requirements

• Ability to lift 30 lbs stand for 2 to 3 hours at a time sit for 2 to 3 hours at a time walk long distances and bend to obtain items from lower shelving/cabinets.

• Intellectual capability to perform complex mathematical problems and perform complex data analysis.

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.