پوسٹڈ ان: دوسری/دیگر انرر فلاڈیلفیا | پوسٹ شدہ: |
Job Description
Data Analyst responsibilities include, but are not limited to, the following:
Review laboratory data to ensure all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices
Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia).
Approve Master Laboratory worksheets prior to issuance to Laboratory Operations.
Represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor
Work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time.
Work with Laboratory Operations staff and management to remediate comments and errors in documentation.
Assist Laboratory Operations in conducting investigations associated with laboratory data review.
Utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.
Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors. Maintain metrics and tracking associated with these documentation reviews.
Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.
Perform review and approval of qualification documents as needed.
Ensure that laboratory data is in compliance with cGMPs, GLPs and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.
Responsible for issuance of new and reconciliation of completed laboratory worksheets
Foster a customer service attitude within Laboratory Operations
Provide support to Regulatory Agency inspections as needed.