Sr. Quality Assurance Specialist III - Batch Release

Company: Randstad USA
Location: Garland
Posted on: November 19, 2021

Job Description:

Essential functions
Adheres to all policies and procedures.
Ensures individual training is maintained and documented.
Initiates and drafts Quality events such as (Deviations, CAPA, Investigations, Change Controls, etc.) as requested associated with the review of manufacturing and packaging records.
Works directly with internal cross-functional areas.
Provides and maintains information in support of Quality Metrics.
Revise, review, and approve Standard Operating Procedures (SOPs) associated with the Batch Release function.
Revise, review, and approve proposed/new Manufacturing, Packaging and labeling records prior to implementation.
Performs Quality review and approval of completed manufacturing, packaging, and labeling records.
Perform technical review of data, as required.
Develops COA and COC documents.
Provide and support Product Release process.
Review and approve raw material, packaging, and labeling component release.
Review and approve finished product shipping.
Initiate Disposition of Rejected Item process and reconcile destruction activities monthly.
This role ensures and maintains the organizations compliance with Food and Drug. Administration (FDA) 21 CFR Part 4, 11, 210, 211, and 820 compliances.
Ability to monitor and report on assigned tasks, goals, and objectives.
Perform other tasks as assigned.

Required Education and Experience
Bachelor's degree required preferably in the areas of science or technology (i.e., chemistry, micro-biology, biology, engineering, etc.)
8 years (minimum) of experience working in a cGMP pharmaceutical manufacturing environment.
Must have experience/knowledge of drug product manufacturing processes in a cGMP environment.
Ability to exercise judgment with defined procedures and practices to determine appropriate action.
Knowledge in the pharmaceutical regulations (i.e., 21 CFR Parts 4, 11, 210 and 211, as well as 820).
Excellent written and oral communication skills.
Computer literate with working knowledge of Microsoft Office applications.
Demonstrated ability to plan and work independently with a demonstrated ability to execute tasks and logical plan for task execution & follow-up.
Demonstrated high level to detail and organization in task management.

Keywords: Randstad USA, Garland , Sr. Quality Assurance Specialist III - Batch Release, Other , Garland, Texas