Safety Lab Quality Coordinator, Clinical Research Unit

  • New Haven, CT

Compensation

: $69,840.00 - $100,940.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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JOB SUMMARY
The Lab Quality Coordinator is responsible for implementing routine and special clinical laboratory testing using automated, semi-automated, and/or manual methods and equipment for hematology, chemistry, urinalysis, and coagulation assays. Although this individual may perform these assays, the primary focus of this role is to enhance quality of laboratory testing. As such, the individual will assume a major role in laboratory accreditation processes, audit requirements, quality control and quality assurance processes within the laboratory. Involved in, and may lead, quality event and quality improvement processes.

JOB RESPONSIBILITIES
  • Works with the Laboratory Manager to execute accreditation processes, requirements, and inspections. Prepares responses to audit findings.
  • Involved in the documentation and resolution of quality events.
  • Highly involved, and may lead, quality improvement initiatives.
  • Develops and maintains quality processes and SOPs in the Safety Laboratory.
  • Writes new SOPS.
  • Evaluates quality control and instrument maintenance logs as designated by Laboratory manager.
  • Prepares Quality Event documentation and CAPAs to address quality issues.
  • Perform routine and special clinical chemistry, hematology, coagulation, and urinalysis as needed. This will allow the individual to be closely aligned with laboratory processes to visualize areas of improvement.
  • May serve as an instrument key operator, as needed.
  • Perform, implement, and/or validate new instrumentation and assays.
  • Participates in quality lab projects and has a strong working relationship with the Quality Management group.
  • Evaluates and creates solutions to minimize pre-analytical, analytical, and post-analytical specimen processing issues.
  • Assures compliance of processes for all activity in the Safety analytical laboratory.
  • Works to improve efficiency within the laboratory.
  • Participates in multi-functional quality initiatives and is closely linked to the Quality Management group.
  • Process laboratory samples for shipping if needed.
  • Performs training as assigned and trains others as needed.
  • Maintains a safe and clean working laboratory environment.

QUALIFICATIONS / SKILLS
  • An Associate's degree in Medical Technology with ten years of experience or a Bachelor's degree in Medical Technology with five years of experience is required.
  • ASCP (American Society of Clinical Pathology) MLT or MT certification is also required. Additional quality certification is preferred but not required.
  • The individual should have experience in both hospital and pharmaceutical laboratory settings. The individual must demonstrate knowledge in Good Clinical Practice (GCP) laboratory regulations, CLIA, CAP, and COLA laboratory inspection processes.
Additional qualities desired include:
  • Strong verbal and written communication skills.
  • Detail-oriented and well organized.
  • Ability to implement process improvements
  • Ability to use laboratory computer systems to view, enter, and interpret data
  • Working knowledge of Excel, Outlook, Word, and PowerPoint

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.

Other Job Details:
  • Eligible for Employee Referral Bonus


#LI-PFE
1 (First Shift) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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