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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
- 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.