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Quality Control Senior Associate Scientist , Microbiology (Weekend Shift (Fri-Mon))

Employer
Pfizer
Location
Sanford, North Carolina
Start date
Sep 22, 2022

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Discipline
Quality, Science/R&D, Biotechnology, Microbiology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC, Best Places to Work
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Job Details

ROLE SUMMARY

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 Good Manufacturing Practices (GMP) tasks/activities associated with maintaining compliant Quality Control and Stability laboratories; testing; analyzing, interpreting, and trending results/data; creating, reviewing, executing activates for, and approving documentation; participating in and/or leading investigations of events/Out of Specification (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; assists in regulatory and internal audits.

This position is focused on Microbiological assays. Experience in bioburden, viable count method (serial dilution), sterility, microbial identification, and culture purity is preferred. Analyst would be a Senior Analyst responsible for ensuring routine testing is scheduled, completed, and reviewed within the required time frame. Analyst would be available for trouble shooting and to direct/coach junior analysts. Other responsibilities would include Standard Operating Procedure (SOP) revisions, qualification/validation support, as well as represent Quality Control (QC) Microbiology in meetings and during internal and regulatory audits. Analyst may be required to perform testing as needed for supporting lab functions.

The individual should be considered able to demonstrate the following:

  • Acting safely, knows and follows all Environmental Health & Safety (EH&S) 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

  • 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 Corrective Action/Preventative Action (CAPA) within own work area under limited guidance

  • Capability of detailing requirements for Laboratory Information Management System (LIMS) builds and/or building and testing new LIMS builds and LIMS Master Data changes

ROLE RESPONSIBILITIES

  • Responsible for knowing, understanding and acting in accordance with Pfizer’s values.

  • Performs tasks associated with maintaining current Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories.

  • Performs testing as needed to support lab functions.

  • 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 (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 including review.

  • 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

  • BS/BA Degree in Science/related field with 5 - 7 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry required; OR

  • MS Degree in Science/related fieldwith 2 - 4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry required

  • 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

  • Excellent effective written and verbal communication and interpersonal skills

Nice-to-Have

  • Experience in bioburden, viable count method (serial dilution), sterility, microbial identification, and culture purity is preferred

  • cGMP Laboratory experience preferred

  • Knowledge of and experience with the following are preferred:

    • US, EU, and ROW cGMP; pharmacopeias; ICH guidelines

    • Analytical chemistry and/or Microbiology techniques and instrumentation

    • Computer systems including: 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

    • Documentation systems

    • Quality Risk Management including risk assessments

PHYSICAL/MENTAL REQUIREMENTS

  • Physical or 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

  • Non Standard Work Schedule, Travel or Environment Requirements

  • Work schedule will be weekends Friday- Monday. 7a start time

Other Job Details:

  • Last Date to Apply:September 23rd, 2022

  • Relocation Assistance Eligible

Relocation assistance may be available based on business needs and/or eligibility.

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 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

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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