Batch Record Revision Consultant - Lenexa, KS (REF9299F)

22 Nov 2024

Vacancy expired!

Job Description

Summary: Performs activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and company Standard Requirement Documents in an FDA-regulated, biologics manufacturing environment.

  • Reviewexecuted manufacturing records and batch records.
  • Implementation of a batch record revision project.
  • Sterile and Non-Sterile Filling (no solid dose)

Qualifications

Education And Experience

  • Bachelor’s Degree (BS or BA) in a science-related field (i.e. math, chemistry, biology)
  • 4+ years of experience working in Quality specific to Batch Record Review
  • Background of working in Drugs or Biologics Manufacturing
  • Experience in change control, deviation management and correction

Position Requirements

  • Must have strong knowledge of current Good Manufacturing Practices (GMP), FDA and EU regulations and guidance
  • Demonstrated experience with electronic quality tracking systems
  • Understanding of biologics manufacturing operations is preferred
  • Good organizational skills and attention to detail
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross-functionally.
  • Ability to handle multiple assignments and changing priorities.
  • Ability to learn and utilize computerized systems for daily performance of tasks
  • Ability to prioritize, manage multiple tasks, and meet deadlines

Additional Information

All candidates must be legally eligible to work in the United States.We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

  • ID: #23284503
  • State: Kansas Lenexa 66215 Lenexa USA
  • City: Lenexa
  • Salary: USD TBD TBD
  • Job type: Contract
  • Showed: 2021-11-22
  • Deadline: 2022-01-21
  • Category: Et cetera