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Form of workJob Description
Position Summary:
Title: Sr Associate
Location: Thousand Oaks
Tax Term: W2
Duration: 11-12 Months (Possibility of extension)
Description:
Onsite - Thousand oaks site.
Typically schedule 8-5 once a month or every two weeks the person will need to work off shift for audit assessment.
That shift is one day from 2pm-11pm or 6am-2pm depending on the need.
Ideal candidate: not entry level, must have around 2+ YOE, Must have GMP experience, maintenance in manufacturing. Experience revise documents, owning some of the CAPAs, participate in investigations related to deviations, safety events.
Biotech, pharma, background.
The Senior Associate Facilities Maintenance will provide support to Manufacturing Clinical Supply Facilities and Engineering (MCS F&E) for activities related to Integrated Facilities Management (IFM). This individual with the direction from MCS F&E Management will be working with cross-functional teams that includes members from Integrated Service Providers, Site Quality, and Manufacturing. Prefers Bachelors degree.
Responsibilities:
o Provide oversight support of Integrated Facilities Management (IFM) within MCS
o Perform revisions of Standard Operating Procedures
o Own Corrective Action Records related to IFM Scope
o Perform periodic audits/assessment of areas supported by Integrated Service Provider (ISP) during on shift and off shift hours
o Lead or participate in investigations related to deviations, safety events, pest control, etc
o Support metrics gathering and analysis
o Support preparation of Quarterly Pest Trend Report
o Support Quarterly Data Integrity assessment
o Support key deliverables and/ or projects as part of Integrated Facilities Management
Basic Qualifications
0+ Years w/ Relevant MS OR equivalent 2+ Years w/ Relevant BS OR equivalent 4+ Years w/ Relevant AS OR equivalent 6+ Years w/ HS
Top 3 Must Have Skill Sets:
1. Previous experience with facilities management or maintenance of a regulated Manufacturing Area (GMP Manufacturing)
2. Demonstrated experience with document revision and root cause analysis
3. Proficient in MS Office Software
Day to Day Responsibilities:
Responsibilities:
o Provide oversight support of Integrated Facilities Management (IFM) within MCS
o Perform revisions of Standard Operating Procedures
o Own Corrective Action Records related to IFM Scope
o Perform periodic audits/assessment of areas supported by Integrated Service Provider (ISP) during on shift and off shift hours
o Lead or participate in investigations related to deviations, safety events, pest control, etc
o Support metrics gathering and analysis
o Support preparation of Quarterly Pest Trend Report
o Support Quarterly Data Integrity assessment
o Support key deliverables and/ or projects as part of Integrated Facilities Management
