Specialist, QA Release
Perks & Benefits:
Duties & Responsibilities
- Documentation Review/Approvals:
- Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards.
- Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.
- Resolves major issues that are not defined by SOP.
- Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release.
- Performs review and approvals of APHIS Form 2008s against applicable Outlines of Production for submission to the USDA for all serial releases.
- Performs review and approvals of MBPS/CBRs/international permits for international releases.
- Creates and revises export documentation as changes occur.
- Change Control:
- Performs review and approvals of change controls as a subject matter expert (SME) in QA Release for routine change controls.
- Completes change control action items as assigned.
- Revises existing procedures as changes occur.
- Deviations/CAPA:
- Initiates deviations in Quality electronic systems when non-conformances are detected during documentation review.
- Writes or participates in deviation investigations for determination of appropriate root causes.
- Performs follow-up on CAPAs for completion.
- SAP:
- Performs movement transactions in SAP system of product as needed.
- Performs usage decisions for batch release in SAP
- Performs second check in SAP prior to batch release.
- Projects:
- Actively participates on project teams as assigned by supervisor
- Coordinates and leads projects with supervision.
- Coordinates and leads projects within group without supervision.
- Training:
- Completes all assigned training by target due dates as assigned by BIAH.
- Completes on the job training for each assigned job task.
- Cross trains on other job tasks within department.
- Assists with training other individuals within the department onspecific tasks.
- Performs training other individuals within department per assigned training plans.
- Assists QA management with the development of training plans within department and trains others.
- Inspection:
- Performs 2nd review/release approval of serials/lots.
- Initiates non-conformance reports for serials/lots that do not meet requirements.
- Routinely reviews specifications/ standards/ inspection plans for compliance to current regulatory requirements.
- Regulatory:
- Demonstrates understanding of regulations for various countries.
- Audits/Inspections:
- Participates in internal audits as assigned by management.
- Serves as an SME for strategy rooms during internal and external audits/inspections.
- Identifies, creates CAPAs and tracks them through to completion.
Requirements
- BS degree from an accredited institution in a relevant scientific discipline, plus two (2) years of relevant experience required; or MS degree from an accredited institution in a relevant scientific discipline
- NOTE:Relevant BIAH experience may be weighted more significantly.
- Requires ability to utilize computer programs such as Microsoft suite, SAP,IDEA for CON, Learning One Source and other relevant electronic applications.
- Exceptional logical skills with excellence in written and verbal communication skills.
- Excellence in comprehension/application of USDA and EU regulatory requirements for production and distribution of regulated biological articles.
- Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks.
- Ability to make decisions with some supervision regarding the acceptability of product based on documentation provided.
- Excellent attention to detail.
Desired Skills, Experience and Abilities
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