QC Senior Associate Scientist, Stability

Use Your Power for Purpose
At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need.
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 documentation; detailing requirements and requesting LIMS (Laboratory Information Management System) builds and master data changes; Support stability regulatory submissions document creation; support 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.
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
• sufficient depth of knowledge within stability and previous area of experience
• good effective written and verbal communication and interpersonal skills
• ability to follow written procedures and learn from hands on training
• capability of solving complex mathematical and situation dependent problems
• ability to receive feedback 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, detail oriented
• 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
• support training of new staff within immediate team; mentoring and coaching junior colleagues
• able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching
• experience assisting with laboratory investigations to define root cause and assisting with validation protocol non-conformances
• method 1, yellow belt trained and/or understands use of tools and can apply them to solve issues (including technical issues)
• makes good decisions based on knowledge of quality systems/technical experience and work is accurate with little to no errors
• recognizes the impact of procedural changes that may impact future quality tasks and decisions
• applies discipline's principles and appropriate procedures to design and execute work against work group goals
• able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments
• responsible for personal timelines delivery and seeks advice if conflicts arise
• interacts with business lines and shares information with team; capable of influencing and negotiating with business lines
• increased ability to communication effectively with good interpersonal skills; establish relationships within Quality lines

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.
ROLE RESPONSIBILITIES
Performs tasks associated with maintaining cGMP compliant Stability and Stability area/equipment.

• Completes activities to implement Stability protocols and studies
• Forecasting for QC Labs expected Stability pulls and performs Stability pulls
• Completes actions for end of studies and sample disposal
• Metric tracking and reporting
• Providing investigation support and troubleshooting stability issues
• Maintenance and continuous improvement of Stability procedures and processes
• Support Stability regulatory submissions document creation and review
• 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
• 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 bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
  OR an associate's degree with 6 years of experience; OR a high school
  diploma (or equivalent) and 8 years of relevant experience
• Understanding of laboratory practices and processes
• Successful hands-on analytical testing experience in a GMP environment.
• E xperience training and/or mentoring junior staff
• Ability to handle multiple tasks concurrently and in a timely fashion
• Familiar with LIMS.
• Capable to read, understand, and execute instructions in basic laboratory procedures

Bonus Points If You Have (Preferred Requirements)

• Willing to learn and develop a career in the pharmaceutical industry
• Capable to read, understand, and execute instructions in basic laboratory procedures
• Demonstrates engagement in helping to achieve laboratory, team, and individual goals.

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.
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.
OTHER JOB DETAILS
Last Date to Apply for Job: 4/23/25
Work Location Assignment: On Premise
The annual base salary for this position ranges from $66 500,00 to $110 900,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7,5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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