Pfizer QC Senior Associate Scientist, Stability in Sanford, North Carolina
What You Will Achieve
The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities in support of Stability. Key responsibilities are performing GMP tasks/activities associated with maintaining compliant Stability studies and Stability area/equipment; creating, reviewing, executing activates for, and approving documentation; detailing requirements and requesting LIMS (Laboratory Information Management System) builds and master data changes; stability regulatory submissions document creation and review; initiate and project manage change controls; support audits as Stability subject matter expert; analyzing, interpreting, and trending results/data; participating in investigations of events/out of specification results; acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations; represents Quality Control on cross functional teams; and leads projects and/or teams providing guidance/training/coaching to junior colleagues.
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 audits and investigations, reviewing/approving technical content to ensure scientific merit and 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
solving highly complex problems and situation dependent problems using convoluted information
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 create, review, and approve compliant equipment qualification/computer validation records; assist with protocol non-conformance evaluations
able to identify and seek out external resources to build or enhance understanding of stability concepts and compliance; supports training of staff; mentoring and coaching junior colleagues
capability of detailing requirements for LIMS builds and LIMS Master Data changes
How You Will Achieve It
Responsible for knowing, understanding and acting in accordance with Pfizer's values
Performs tasks associated with maintaining cGMP compliant Stability and Stability area/equipment.
Completes activities to implement Stability protocols and studies for new products and annual stability for commercial products
Forecasting for QC Labs expected Stability pulls and performs Stability pulls
Evaluates change control for Stability impact
Conducts stability impact assessments for investigations
Completes actions for end of studies and sample disposal
Stability APR review
Conducts shipping stability samples to contract labs, and enters contract lab data into LIMS
Metric tracking and reporting
Providing investigation support and troubleshooting stability issues
Maintenance and continuous improvement of Stability procedures and processes
Stability regulatory submissions document creation and review
Responsible for requesting detailed LIMS builds and LIMS Master Data changes.
Responsible for appropriate creation, review, approval and final authorization of GMP documentation (test results and records, equipment validation protocols/reports, equipment records, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
May analyze and interpret results, make decisions regarding their completeness and compliance; may perform data trending
Responsible for reporting issues to management and participating in issue resolution
Initiate and project manage change controls
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.
Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience.
Understanding of laboratory practices
Skilled in word processing and document formatting; experienced in Microsoft Office applications (Word, Excel, PowerPoint,Visio)
Understanding of cGMP and Safety regulations.
Strong organizational and communication skills
Individual should have knowledge of US, EU, and ROW cGxP; ICH guidelines; analytical chemistry and/or Microbiology techniques; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.
Limited travel for the position; no more than 10% traveling.
Work Location Assignment:On Premise
Last Date to Apply for Job: March 30, 2023
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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