Sr Associate Scientist - Standards & Controls

Pfizer

68d • $66,500 - $110,900

About The Position

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.

Requirements

• Bachelor's degree with at least 3 years of experience; OR a master's 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.

Responsibilities

• Perform GMP tasks associated with maintaining compliant Quality Control and Stability laboratories.
• Analyze, interpret, and trend results.
• Create, review, and approve documentation.
• Lead safety initiatives and encourage others to act safely.
• Support documentation management and ensure compliance to regulations and Pfizer policy.
• Represent Quality Control on site and network teams/forums.
• Identify and implement documentation best practices to continuously improve site performance.
• Manage multiple initiatives simultaneously and communicate progress to stakeholders.
• Train junior colleagues and develop training plans.

Benefits

• 401(k) plan with Pfizer Matching Contributions.
• Paid vacation, holiday and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees