Job Description

Description: Duties and Responsibilities
The QA Specialist Demonstrates sufficient depth of knowledge within own work area in order to perform hands-on routine QA tasks. This role supports Operations including batch record, investigation, and document review, and disposition activities. Resolve routine quality issues related to product manufacture and testing with guidance/coaching. Project work, as needed, will also be expected. Other essential duties and responsibilities in quality assurance include: Provide Quality Assurance expertise to colleagues On and off the Manufacturing floor as required. Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with ***'s standard processes and quality systems. Conduct regular Production areas walkthroughs (Area product clarences, GMP and compliance walkthroughs) Conduct On floor QA review of executed batch records and Logbooks to assure compliance with regulatory standards and regulatory filing. Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations. Escalate issues as appropriate to the Quality Assurance Management in a timely manner. Maintain regulatory compliance in accordance with current Good Manufacturing Practices. Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives. Quality Assurance approval of SOPs, Campaigns start up Form and QA validation protocols and reports. Maintains inspection readiness and supports internal/external audits as needed. Interface with Regulatory Agencies in audits. Ability to work in a fast-paced environment and be able and willing to juggle priorities as required.
PHYSICAL/MENTAL REQUIREMENTS Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate. Ability to stand for 1 hour at a time, walk long distances and bend to obtain items from lower shelving/cabinets. Occasional minimal lifting up to 20lbs.


Shift: Monday - Friday / First shift
Interview: Teams Meeting


Custom Fields:
Name: Is this position a Sunshine Act position?
Value: No


Name: Department
Value: Quality Assurance


Name: Hours of overtime
Value: None


Name: GL Account
Value: 41160000


Name: Will overtime be needed?
Value: No


Name: Minimum Education
Value: Bachelor's degree with 1-2 years of experience in GMP Pharmaceutical manufacturing environment required.


Name: Work Environment
Value: Onsite


Name: WBS Element
Value: None


Name: Special Clearances / Medical Surveillance
Value: {items=[{itemValueId=4bb58a02-b4db-42f5-a***28b69, itemValue=Quality inspector}]}

Job Tags

Long distance, Monday to Friday, Shift work, Day shift,

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