Quality Assurance Specialist
1 week ago
Position: Quality Assurance Specialist
Compensation: $24-$26/hr
Contract Type: W2 Contract (potential for extension)
Location: Onsite
Role Summary:
The Quality Assurance Specialist will engage in a variety of tasks to uphold the Quality Management System.
Key Responsibilities:
- Execute product evaluations, including assessments for complaint investigations and stability checks.
- Compile and present product testing outcome reports.
- Examine production batch records for precision and thoroughness to authorize intermediate products for production use. Assess finished goods batch records, reporting any discrepancies and ensuring resolution before granting approval.
- Conduct random inspections and audits of production processes.
- Participate in the internal auditing framework.
- Draft, review, and endorse Standard Operating Procedures (SOPs) as needed.
- Support the Document Control program, including record retention and sample preservation.
- Assist with the processing of returned instruments, including:
- Logging returned instruments.
- Decontaminating returned instruments in a controlled environment following established procedures.
- Inspecting returned instruments for damage and documenting findings prior to further processing.
- Managing instrument documentation for repair and packaging as necessary.
Qualifications:
- Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Bachelor's degree in a scientific or technical field or equivalent experience. A minimum of one year in a quality assurance role within the medical device sector is preferred.
- Ability to interpret safety regulations, operational instructions, and procedural manuals. Proficient in writing standard reports and communicating effectively in small group settings.
- Competence in applying mathematical concepts such as fractions, percentages, and ratios to real-world scenarios.
- Proficient in using database, internet, inventory, spreadsheet, and word processing software.
- Strong adherence to procedures and meticulous documentation of results.
- Understanding of manufacturing processes and the ability to identify deviations from established procedures.
- Exceptional attention to detail.
- Capability to utilize cleaning agents as required.
While performing the responsibilities of this position, the employee is regularly required to sit and stand, with occasional walking involved.
Work Environment: The characteristics of the work environment are typical of those encountered while fulfilling the essential functions of this role. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential functions. The noise level in the work environment is generally quiet.
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