QC Senior Scientist

Use Your Power for Purpose

The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, and validation.  Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing, analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.

Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.

What You Will Achieve

In this role, you will:

• Acts safely and follows all EH&S safety requirements for site and QC laboratories.
• Be recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards. 
• Excellent written and verbal communication skills
• Ability to identify issues, present complex problems with possible solutions, and actively take a leadership role to resolve issues.
• Ability to solve highly complex mathematical problems and situation-dependent problems using convoluted information.
• Ability to receive feedback from management and colleagues and take accountability for actions and personal development.
• Aptitude for good decision making based on procedures, guidance, and experience.
• Awareness to know their own limitations and seek senior scientist or management guidance when appropriate.
• Desire to ensure correctness and accuracy in tasks and documentation.
• Fitness of functioning as a team member and performing independent work with minor guidance
• Willingness to use personal skills and knowledge to achieve individual and company goals and objectives.
• Understanding of own area of function and knowledge of other cross functional areas
• Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching.
• Understands the importance of feedback and receives feedback well from management and other colleagues.
• Makes good decisions based on knowledge of quality systems and technical experience.
• Recognizes the impact of procedural changes that may impact future quality tasks and decisions.
• Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations.
• Responsible for personal timelines and seeks advice if conflicts arise.
• Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines.
• Ability to communicate effectively with good interpersonal skills.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.
• Able to create, review, and approve compliant test methods and training materials.
• Perform tasks associated with maintaining Current Good Manufacturing Practices (part of GxP), compliant Quality Control, and Stability laboratories.
• Support preparation of reagents, receipt, storage and handling of reagents.
• Perform testing including but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.
• Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.
• Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.
• Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects.
• Perform various inspections of laboratories and surrounding office area as assigned and prepare a report.
• Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities.
• Train junior colleagues and may develop training plans and/or oversee training activities for groups.

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelors with at least 9 years of experience OR Masters with more than 7 years of experience or a PhD with 0+ years of experience.
• Demo