QC Instrument/Equipment Coordinator
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
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, validation, and stability. Key responsibilities are performing GMP tasks/activities associated with maintaining compliant Quality Control; managing the GMP compliance of QC instruments/equipment; creating, reviewing, executing activates for, and approving documentation; participating in investigations of events results; acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations.
The individual should be considered able to demonstrate the following:
acting safely, knows and follows all EH&S 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 mathematical 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 holistically review and authorize all laboratory data, and have an extensive overall knowledge of all laboratory operations
able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records; assist with protocol non-conformance evaluations
able to identify and seek out external resources (e.g. PDA, ISPE) to build or enhance understanding of scientific discipline; supports training of staff; mentoring and coaching junior colleagues
displays strong investigative or technological orientation with independence for design of projects/studies and able to make significant independent contributions to the development of methodology including new technologies and automation
expertise with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited guidance
capability of detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes
Individual should have knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical and instrumentation techniques ; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.How You Will Achieve It
Responsible for knowing, understanding and acting in accordance with Pfizer’s values and our OWNIT culture
Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories.
Responsible for initiating QTS records related to change management to existing analytical equipment and any new analytical equipment enrollments.
Leading projects ensuring all milestones are met.
Escorting vendors for routine analytical equipment maintenance; ensuring vendor training and company qualifications are up to date.
Responsible for appropriate creation, review, approval and final authorization of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.)
Responsible for contributing to and/or handle laboratory investigations for events and OOS results.
Trains junior colleagues and may develop training plans and/or oversee training activities for groups.
Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.
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, lead a working group and/or 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
The minimal education and experience is as follows:
· 2-4 years of manufacturing, quality or laboratory experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field.
· 5-7 years of manufacturing, quality or laboratory experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field.
· 7+ years of manufacturing, quality or laboratory experience in the biotech or pharmaceutical industry with a Associate Degree in Science/related field.
· Experienced and proficient with various laboratory instrumentation/equipment and validation/qualification principles.
· Knowledgeable/experience of change control practices and quality risk management (QRM) concepts.Nice-to-Have
Master's degree and 4+ years of relevant experience
Experience leading continuous improvement projects
Experience defending laboratory practices in regulatory audit.
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
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.
Last Date to Apply for Job: December 6th
Eligible for Relocation Package: NO
Eligible for Employee Referral Bonus: YES
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.Sunshine ActPfizer 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 EligibilityPfizer 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.Quality Assurance and Control#LI-PFE