BioPharma R&D Quality Control Reviewer

Employer
Eurofins Lancaster Laboratories
Location
Lees Summit, MO
Closing date
Dec 6, 2021

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Sector
Pharmaceutical, Quality Assurance
Organization Type
Corporate
Job Description Basic Function and Scope of Responsibility:The BioPharma R&D Quality Control Reviewer will be the designated reviewer for pre-validation and method validation documents, results, and reports. This review supports all documents to ensure a quality assay is established per internal and external expectations.

This is a Full-time position with the following work schedule:Mon-Friday, 8:00am - 5:00pm, with overtime as needed.Please note: Viracor is relocating to our new facility in Lenexa, KS in March 2022Essential Job Duties BP R&D Quality Control Reviewer I
  • Serve as the designated reviewer for pre-validation and method validation documents, results, and reports under the leadership of the Technical Writer Supervisor.
  • Review R&D experimental plans before experiments are executed in the laboratory. These may include dilution schemes, instrument information, method, plate maps, master mix worksheets, and test records.
  • Work closely with the R&D project leads to ensure experiments were executed in accordance with the experimental plans, protocols, and standard operating procedures.
  • Review daily run packets for Good Documentation Practice (GDP) and technical accuracy. This will include completing Quality Control checklists.
  • Review acceptability of pre-validation/validation data and repeats based on sound scientific judgement and validation protocols in a timely manner.
  • Review validation report to ensure validation data has been accurately transferred from the raw data files, computed data, and experimental plans, etc.
  • Assist in key activities supporting quality in the department:
  • Aid implementing quality systems related to pre-validation and validation (e.g., Electronic Lab Notebook, proper utilization of EtQ, approaches to quality control, etc.).
BP R&D Quality Control Reviewer IIAs Above, Plus
  • QC Reviewer II serves to train other reviewers.
  • Support RA/QO department with audit activities.
  • Specified higher level duties in QC, such as
  • Draft or edit SOPs related to Quality Control processes (if applicable).
  • Aid in identifying and tracking patterns in pre-validation / validation deviations.
Qualifications Essential Knowledge, Skills and Abilities:BP R&D Quality Control Reviewer I
  • BS or BA in biological, physical, chemical, or clinical laboratory science.
  • 3+ years' experience in a highly regulated environment required, GCLP or CAP/CLIA preferred.
  • 3 years' experience in method/assay development and hypothesis-driven laboratory research preferred.
Additional InformationWhat We OfferAs a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

Physical Requirements
  • Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other office equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead
  • Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting
  • Ability to continuously operate a personal computer for extended periods of time (4 or more hours)
  • Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgments and decisions
The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

To learn more about Viracor Eurofins, please visit the following websites http://www.viracor-eurofins.com and www.eurofinsus.com

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.All your information will be kept confidential according to EEO guidelines. Viracor Eurofins is committed to promoting an equal employment opportunity workplace environment and is an equal opportunity employer. It is the policy of the Company that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, citizenship, pregnancy, genetic information (GINA), disability, military and/or veteran status, and/or any other status protected by applicable Federal, state, or local law. The Company's policy is to recruit, hire, train, promote and administer all employment-related matters on the basis of an individual's qualifications, abilities and efforts without regard to protected status.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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