banner

Data Reviewer (QC)

BioAgilytix Labs, 2300 Englert Drive, Durham, North Carolina, United States of America Req #49
Tuesday, April 12, 2022
BioAgilytix is a leading contract research organization (CRO) that specializes in large molecule bioanalysis. Our fully integrated laboratory services support every stage of biologics development, from early discovery through pre-clinical studies and clinical phases, in a fully regulated environment. The best science demands the best people, and our global team of professionals in Durham, North Carolina; Boston, Massachusetts; and Hamburg, Germany bring a passion for helping pharma and biotech companies achieve more for the patients they serve.

Our clients trust us to deliver excellence in data and bioanalysis and in this role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays, cell work, gene therapy and more.
 

We are looking for candidates who have practical regulatory experience with bioanalytical data in a corporate GxP setting. This role is not lab-based, but our best candidates have lab experience or experience with the types of assays we do here. You are self-motivated, an independent thinker, and highly organized. If you influence others by being a trusted advisor and advocate, are energized by a deadline-driven environment, and aspire to provide the best caliber of data to our customers, then you’ll be right at home here at BioAgilytix.

 

WHAT YOU WILL DO

  • Perform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP).
  • Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable
  • Issue QC review observations and work closely with the scientific staff to ensure data integrity
  • Collect metrics data used to monitor the QC reviews, and may identify process improvements
  • Assist in educating, guiding and influencing the scientific staff in regard to best practices in GxP compliance

WHAT YOU NEED TO SUCCEED

Competencies and Qualifications Preferred

  • Bachelor’s degree in biological science or related field, with between 2-10 years’ experience working in biotech, pharmaceutical, CRO/CMO or similar organization; or Master’s or PhD. with equivalent experience
  • Knowledge and/or extensive knowledge of GxP regulations
  • Two-Four (2-4) years’ experience performing data review in a GxP environment
  • Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR

Skills

  • Self-motivated and demonstrated ability to learn and work in a fast-paced environment where multiple concurrent projects must be completed in a timely manner
  • Ability to perform your role independently with attention to detail and minimal oversight
  • Ability to perform technical review of data following GxP regulations and scientific principles
  • Expertise in communicating and building relationships with others, where all feel heard and respected
  • The confidence to make and share observations in a considerate manner
  • Proficiency in LIMS and Quality Management software packages
Benefits and Other Perks
  • Medical Insurance (HDHP with HSA; PPO)
  • Dental Insurance
  • Vision Insurance
  • Flexible Spending Account (medical; dependent care)
  • Short Term Disability | Long Term Disability
  • Life Insurance
  • Paid Time Off (4 weeks per year)
  • Paid Holidays (9 scheduled; 3 floating)
  • 401k with Employer Match
  • Employee Referral Program (up to $10k)
  • Free Coffee, Tea, Fruit, and Snacks
  • Discounted Vending Machines (25 cents for everything!)
  • Team Wellness Challenges/Events
Disclaimer
The tasks, duties, and responsibilities listed in this job description are not exhaustive. BioAgilytix, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities to employees. Equivalent experience, skills, and/or education may be substituted for certain requirements, so qualifications of incumbents may differ from those listed in the job description. The Company, at its sole discretion, will determine what is considered equivalent to the qualifications described above. Further, this job description does not constitute a contract of employment, either expressly, or by implication. Comments BioAgilytix requires that all employees be legally authorized to work in the United States. In the event an applicant does not have current work authorization, BioAgilytix will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on USCIS requirements, not all roles are suitable for sponsorship. Equal Opportunity Employer BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

Other details

  • Pay Type Salary
Location on Google Maps
  • BioAgilytix Labs, 2300 Englert Drive, Durham, North Carolina, United States of America