Manufacturing Assurance Specialist
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Manufacturing Assurance Specialist
Location: Vista CA 92081
Duration: 6 Months
Job Description
Summary:
Investigate manufacturing deviations environmental monitoring excursions calibration investigations and summarize the information including determination of assignable cause and impact on the product and/ or production.
Primary responsibilities for role:
- Work closely with the Manufacturing Quality Operations Facilities Quality Control and Quality Assurance departments on a daily basis and help resolve conflicting interests to reach a postive outcome.
- Perform thorough investigations identify root causes and determine corrective actions Perform Facility and Utility Area Inspections and report any findings with potential production impact to department and area manager.
- Generate formal written reports that summarize findings and corrective/ preventive measures to reduce the potential for recurence.
- Assist in CAPA generation execution implementation DCM Submission Plant change control or similar.
- Review manufacturing Facilties Environmental monitoring documentation and other documentation as needed to complete an investigation and summarize the findings. Maintain current knowledge of regulatory and industry standards Work and make decisions independently with limited supervision.
- Supervised by a senior professional.
- Additional Responsibility Must be flexible with working hours/ shifts in order to accommodate a 24 hour - 7 days/ week plant operation.
Knowledgeskills and abilities:
- Direct hands on experience with manufacturing validation and/ or aseptic processing is required. Must have strong technical writing skills.
- Strong organizational analytical and problem solving skills with the ability to make structured decisions.
- Must be proactive results oriented and have a strong attention to detail. Interpersonal skills with the ability to interact with personnel at all levels in a team environment. Computer literacy with proficiency in Microsoft (Word Outlook Excel) DCM SAP LIMS
Occupational Demands:
Ability to lift/push 40 lbs. Must be able to work in a clean room (sanitized) environment. Must be able to fully gown. Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Key Skills
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