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Sr. Labs Compliance Specialist

Employer
Pfizer
Location
Rochester, Michigan
Start date
Sep 24, 2022

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Job Details

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

This Senior Labs Compliance Specialist role represents the Rochester QC Laboratory on high complexity projects and project teams both within and outside of Quality Operations to include but not be limited to data integrity initiatives, PQS compliance requirements and continuous improvement projects.

The Sr. Labs Compliance Specialist will perform LIR investigations for Atypical results, OOS, Questionable, and Invalidated Data occurrences and will cover data integrity responsibilities for the lab.

This role provides leadership and technical expertise to assist the laboratory with instrument qualifications, method development (as needed), troubleshooting, investigations, computer validation.The Sr. Labs Compliance Specialist will be involved in second checking of data and will perform Laboratory testing as needed.

The Sr. Labs Compliance Specialist will be directly involved in implementation of system conversions (i.e. SAP, LIMS LITE), they may also assist with method improvements as well as other infrastructure support functions.

The Sr. Labs Compliance Specialist may defend QC Laboratory Quality Systems during audits and inspections.

How You Will Achieve It

• Leads and documents laboratory investigations for procedural deviations, atypical, OOS, questionable, and invalidated data occurrences.

• Assures adherence to data integrity initiatives.

• As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO. Leads medium or high complexity project teams within QO tasked with improving laboratory or other quality systems.

• Determines scheduling priorities and workload distribution to ensure customer needs are met with minimal guidance from QO Lab leadership.

• Proactively identifies opportunities for improvements to procedures/processes and actively drives those improvements.

• Manages the balance of daily workload and customer priorities within the team with minimal guidance from QO Leadership.

• Performs 2nd check of laboratory data packets

• Performs analytical assays and microbiological testing (i.e., sterility, LAL, Water testing, Growth promotion).

• Partner with validation and completes lab related instrument qualifications.

Demonstrates a technical mastery of chromatography.

• Applies knowledge of advanced techniques and procedures with recommendations and implementation of new or modified procedures or instrumentation for improved lab efficiency.

• Trains others in the theory and practice of both laboratory techniques and quality systems including investigations, instrument qualifications, etc.

• Independently writes SOPs, technical reports, project plans, instrument qualifications, etc.

Qualifications

Must-Have

  • Applicant must have a High School Diploma (or equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR bachelors with at least 3 years of experience OR master with more than 1 year of experience.
  • Prior experience with instrument qualification, SOP revisions.
  • Ability to receive feedback and takes accountability for actions and personal development
  • Excellent effective written and verbal communication and interpersonal skills
  • Basic computer skills, such as data entry, with a high level of attention to detail, are also required

Nice-to-Have

  • Laboratory and Quality Investigation experience
  • Chemistry Laboratory experience, including HPLC
  • Experience in investigating and documenting out of specification laboratory results.


Work Location Assignment:On-Premise

PHYSICAL/MENTAL REQUIREMENTS

Must NOT be allergic to Penicillin.

Laboratory and office work requiring walking, standing, and sitting throughout a shift. Lifting of items less than 25 kg. Must have the ability to maintain mental focus on multiple complex challenges throughout a shift.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

There is no routine travel.Normal work hours are Monday - Friday 0800 a.m. - 04:30pm. Work outside of core work hours / weekdays will occasionally be required to support projects, investigations, etc. as defined by business need.

Additional Information

  • No relocation support available.

Last Date to Apply for Job: October 7, 2022


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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