QC Associate

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Sep 15, 2020
Ref
4792457
Discipline
Quality, Quality Control
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 an Associate scientist, your strong foundation in general scientific practice and in the principles and concepts of the discipline will help us achieve our goals. You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge.

It is your dedication and focus that will make 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; testing; analyzing, interpreting, and trending results/data; participating in events/OOS results; acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations.

This position is focused on Microbiological assays (e.g. bioburden, viable count method (serial dilution), sterility, microbial identification, culture purity, media certification is preferred). Analyst would be a Laboratory Analyst responsible for ensuring routine testing is completed, within the required time frame. Other responsibilities could include SOP revisions, qualification/validation support, leading/participating in projects.

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
  • Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines
  • Applies discipline's principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals
  • 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
  • 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
  • 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 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.
  • Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories.
  • Performs testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and EM samples.
  • Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending
  • Responsible for appropriate creation 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 detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.
  • 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.
  • Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.
  • 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.

BASIC QUALIFICATIONS
  • BS/BA Degree in Science/related field is required, with experience in biotech or pharmaceutical industry is preferred OR a combination of education and prior experience in the biotech or pharmaceutical industry is required.


PREFERRED QUALIFICATIONS
  • 0 - 3 years of prior manufacturing, quality or engineering experience in the biotech or pharmaceutical industry experience with and in depth understanding of Microbiology testing is preferred.
  • Experience defending laboratory practices in regulatory audits
  • In-depth knowledge of viable and non-viable environmental monitoring during pharmaceutical manufacturing and an understanding of aseptic techniques

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 mathematical problems and perform 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: 9/29/20
  • 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