Quality assurance specialist - united states, allentown
adecco is looking for a motivated, hardworking candidate to fill a quality assurance specialist role, near allentown, pa.
shift: 1st
pay: $18-$22 based on experience.
position summary: work directly with senior quality specialists to assist with release of product off of quarantine within the erp system. assists with the preparation of supporting documentation for batch record review. performs archival of completed batch records. key responsibilities: customer focused. flexible team player. excellent oral and written communication skills. experienced in dealing with customers and suppliers. skilled problem solver with a results orientation. strong computer and analytical skills, including: microsoft excel, access, and word. minimum two years' experience working in a fda current good manufacturing practices (cgmp) environment. associate's degree preferred or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics. non-negotiable hiring criteria: ability to work independently. ability to adhere to strict timelines and work in a fast-paced environment. this position has not been approved for relocation assistance
responsibilities of this role include, but are not limited to:
collecting all supporting documentation from process owners/smes to support the change request, including but not limited to supplier supplied documentation and in-house data.
documenting the change proposal per lcd procedures
route all changes for impact assessments and signatures
logging and issuance of change requests to impacted areas for completion of tasks via the document control process
performing follow-up activities with process owners/smes to ensure all implementation tasks are completed and documented in the change management system by tracking of task completion to ensure closure of change required deliverables
performing records retention activities to ensure change management records are readily retrievable
drafting and routing of customer notifications as required
generating task related metrics and presenting to project managers/leadership
knowledge, skills, abilities
knowledge of the most recent version of iso9001. fda gmp a plus
skilled at reporting metrics showing performance and trending
ability to manage numerous priorities and activities in parallel
excellent verbal and written communication skills; ability to write reports required.
excellent organizational skills and be detail oriented.
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
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