Data Manager (Pharmaceutical/Biologics) - BB52820-1

Full Time
Devens, MA 01434
Posted
Job description

Support Data Trending Contractor/Data Manager (Pharmaceutical/Biologics)
Location: Devens, MA. This is a Hybrid role 50/50
Work Schedule: Mon - Fri, Business Hours

Duration: 12+ Months
Summary:
To support QC methods and instrument performance by monitoring and analyzing invalid rates, using statistical tools, to monitor variation of reference standard data and critical reagents allowing for reaction to adverse trends within the QC Labs ensuring consistent performance.

Responsibilities:

  • Monitor and analyze analytical method performance using statistical tools.
  • Provide support during PMI/LES application maintenance related activities.
  • Support data/analysis requests for APR/APQR, investigations, and analytical method changes within PMI and LES

applications.

  • Support optimization and improvements of analytical method performance data assessments and trending.
  • Support investigations related to release and method performance (OOT).
  • Support data mining, collection, and verification to support local trending and network initiatives.
  • Support writing of technical reports, APQR, SAE Checklists and MPSAE Checklists.

Qualifications:

  • Minimum BS degree with 2+ years relevant life-science industry experience (pharmaceutical/biologics)

preferably in a QC environment.

  • Knowledge of biologics laboratory settings, GMPs, and support disciplines and the basic principles of each.

Knowledge and understanding of regulatory and technical data trending requirements and associated processes.

  • Strong understanding/knowledge of Aegis (Discoverant), SAP, Sample Manager, LES, Empower and Infinity

preferred.

  • Ability to work collaboratively with all employees at all levels.
  • Proficiency in Windows XP, Windows Server 2000, Windows 2003 Server, Oracle, SQL Server.
  • Ability to perform well in a team-based environment.

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types: Contract, Temporary

Pay: Up to $69.00 per hour

Benefits:

  • Dental insurance
  • Health insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Application Question(s):

  • What City/State are you currently located in?
  • What hourly rate are you seeking on a W2?

Education:

  • Bachelor's (Required)

Experience:

  • QC environment: 1 year (Preferred)
  • Aegis (Discoverant), SAP, Sample Manager, LES: 2 years (Preferred)
  • Windows XP, Windows Server 2000: 1 year (Preferred)
  • Windows 2003 Server, Oracle, SQL Server: 1 year (Preferred)
  • pharmaceutical/biologics: 2 years (Preferred)
  • biologics laboratory settings, GMPs: 2 years (Preferred)

Work Location: In person

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