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Manufacturing Expert Job
Eingestellt von Yoh
Gesuchte Skills: Engineering, Support
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Strong analytical skills to identify root causes and prepare balanced decisions
- Excellent oral and written communication skills, and report writing
- Ability to understand basic functionality of equipment/systems and supporting utility services
WHAT YOU'LL BE DOING:
- Analyze and evaluate interactions between potential causes, test results, process/equipment changes, and process variables to identify root cause and corrective/preventative actions
- Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement
- Determine the breadth of discrepancies and insure appropriate Stakeholders in other organizations are made aware of a potential similar issue in their area
- Write concise, accurate and effective discrepancy reports that meet compliance expectations
- Generate appropriate written documentation to support rationale/justification for decisions made regarding potential impact/risk and product disposition
- Influence direction of investigations and communicate with all levels of employees
- Use the Discrepancy Management system/database at an expert level to perform data entry and data-mining, in the support of both investigations and report-outs
- Maintain Conformance KPI information, API QMR information, and API Process Review information
WHAT YOU NEED TO BRING TO THE TABLE:
- Minimum Education B.S. degree in a Science related field, ie Engineering, Biology, Chemistry, etc.
- Minimum Experience Minimum Experience: BS 6+ years, MS 0-4+ years of experience in a related field such as: Engineering, Quality, or Manufacturing in the pharmaceutical industry or an equivalent combination of education and experience
- Experience in performing investigation type work Special Skill/Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc.,
- Experience with regulatory and cGMP requirements for pharmaceutical manufacturing
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Experienced working in a Biotech or Pharmaceutical Manufacturing Industries
WHAT'S IN IT FOR YOU?
- This is your chance to work for a company that cares about your development and helps lead you to where you want to be
IF THIS SOUNDS LIKE YOU, APPLY NOW!
RECRUITER: Dei Blanco
Yoh, a DayJ2W: CLINICAL; MONJOB
TAX TERM: CON_W2J2WNWPHA
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Berkeley, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges