Quality Control LIMS Scientist

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Nov 20, 2020
Ref
4799481
Required Education
Bachelors Degree
Position Type
Full time
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.

Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.

As a Scientist, your deep knowledge in the discipline, will make you an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.

It is your knowledge and skills that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

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, stability and environmental monitoring. Key responsibilities are performing GMP tasks/activities associated with maintaining compliant Quality Control and Stability laboratories; LIMS Master Data analyst functions, analyzing, interpreting, and trending results/data; creating, reviewing, executing activities for, and approving documentation; participating in 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 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
  • capability of determining user requirements, building, and testing LIMS Master Data objects
  • 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/or 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 whena 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


Individual should have knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical chemistry and/or Microbiology techniques and instrumentation; 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.

Responsibilities

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 understanding user requirements for requested LIMS changes.
  • Responsible for building and testing new LIMS objects and LIMS master data updates.
  • Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending
  • Responsible for appropriate creation, review, approval and final authorization of GMP documentation (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 deviations and participating in associated investigations, reporting instrument issues and assisting with troubleshooting, etc.)
  • Responsible for contributing to 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

Qualifications

Must-Have

The minimal education and experience is as follows:
  • 5-7 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
  • 2-4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
  • Or comparable education and/or experience as a LIMS System Administrator

Nice-to-Have
  • LIMS Master Data/ System Administration experience
  • Experience leading continuous improvement projects
  • Experience defending laboratory practices in regulatory audit.
  • Working knowledge of organic chemistry, including degradation mechanisms of pharmaceutical active ingredients and pharmaceutical products

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 is primary first shift, weekdays or 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: 7 December, 2020
  • Eligible for Employee Referral Bonus


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.

Quality Assurance and Control