Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.
As a scientist, your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team. Your skill and knowledge will help in making decisions that require choosing among limited options. Your being proactive in team discussions will help in creating an environment of collaboration.
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/activities associated with maintaining compliant Quality Control and Stability laboratories; analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in and/or leading investigations of events/OOS 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 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.
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); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; project management; formal Quality Change Control, Investigations, Documentation systems, statistical tools (JMP and Informa), and Quality Risk Management including risk assessments.
How You Will Achieve It
Responsible for knowing, understanding, and acting in accordance with Pfizer’s values.
Performs tasks associated with maintaining cGMP compliant process for QC.
Support regulatory audits, as required.
Provide expertise for troubleshooting and resolution of issues related to business processes, equipment, facilities, utilities, and human performance.
Knowledge of laboratory practices, analytical testing, and use of analytical equipment: i.e. UV-VIS, HPLC, UPLC, pH, appearance, osmolality, TOC and conductivity, and various other instruments.
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.
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.
Qualifications
Must-Have
Bachelor’s Degree (3+ years’ experience) or Master’s Degree (0+ years’ experience)
Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations
Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
Understanding of aseptic laboratory techniques and quality systems
Ability to establish relationships within business lines
Nice-to-Have
Experience in Quality Operations
Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA
Excellent effective written and verbal communication and interpersonal skills
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
May need to work off shift hours as required by priorities.
Other Job Details:
Last Date to Apply for Job: December 27, 2024
Work Location Assignment: On Premise
The annual base salary for this position ranges from $78 000,00 to $130 000,00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10,0% 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
