Quality Control Specialist - Specialty Labs

Location: Redwood City, California US

Notice

This position is no longer open.

Job Id: 4703

Position Title: Quality Control Specialist

External Description:

At Precision, we believe that the era of one-size-fits-all medication is giving way to a next generation of treatments, medicines that will be more effective because they are prescribed according to the unique biology of an individual patient. Our mission is to help innovative biotech and pharmaceutical companies accelerate the development of these life-changing treatments. We do this by developing assays that utilize biomarkers to help identify the right patient for the right drug. We also handle every aspect of clinical trials from initial strategy and design to selecting sites and managing trial data.

Quality Control Specialist - the role:
In this position, you will perform several functions associated with quality control and review of laboratory data. The QC Specialist is responsible for the review of designated laboratory data packages for completeness, accuracy, and compliance to Good Laboratory Documentation practices. Both electronic and paper data packages will be reviewed within the Quality Control Team. This role will use programs that collect and evaluate data to assist in assessing and documenting results of the quality control processes. Determines and may assist in developing methods and procedures for improvements and future needs for quality control.

How you will make a difference:
Quality Control Function:

  • Review different types of paper and electronic records which are produced within the scientific teams; this will consist of various work streams: ELISA, MesoScale Discovery (MSD), ELISpot and Flow Cytometry. Focus will be on review of data which is destined to be part of a regulated study and/or which will be reported to a client.
  • Assist in maintaining Quality Control systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of errors which are identified during review
  • Maintain monthly metrics and reporting tools for all aspects of the QC systems
  • Work closely with Quality Assurance team to ensure alignment of the review process for all data
  • Review and provide documents and records for audit and inspection requests

Operations Support:

  • Actively participate in daily operations to assist in helping meet client deliverables; routing data packages and reports to QA
  • Assist in the review of data to help meet customer specifications to conform to contractual requirements
  • Working directly with the scientific leads in the lab, generate and maintain Certificates of Analysis for all critical reagents which are used
  • Provide support to other departments as needed to help with providing on time deliverables
  • Develop and distribute controlled quality system documentation
  • Work with functional groups to develop correct documentation required to document Good Laboratory Documentation practices for data which is to be released to a client
  • Develop and maintain databases/spreadsheets and filing/storage systems for document control and review processes
  • Monitor equipment calibration program to ensure timely and accurate completion of maintenance, as needed
  • Participate in regulatory, notified body, and customer audits as needed

Qualifications:
Minimum Required:

  • Bachelor’s Degree or equivalent combination of education and experience
  • 1-2 years of related experience with Quality Control or document review

Other Required:

  • A high degree of judgment, excellent communication and accuracy of work
  • Ability to meet deadlines and perform administrative functions
  • Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
  • Ability to organize tasks, work independently and adapt to changing priorities
  • Ability to function independently in a minimally supervised environment with exceptional attention to detail required
  • Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
  • Able to read, write, speak, fluently and comprehend the English language

Division: Precision For Medicine

Business Unit: Specialty Lab Services

Office Based: Redwood City - 2686 Middlefield Road, Suite C, D, & E, Redwood City, CA 94063

Employment Type: Non Exempt

Employment Status: Regular Full-time

Work From Home Available: No

City:

Country: United States

State:

Community / Marketing Title: Quality Control Specialist - Specialty Labs

City: Redwood City

State: California

Country: United States

Company Profile:

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

EEO Employer Verbiage:

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

Location_formattedLocationLong: Redwood City, California US

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

Privacy Policy

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

© 2018-2020 Precision Medicine Group, LLC. All rights reserved