Engineering Investigation Specialist-MS&T - Temp (On-Site)

Tolmar • Windsor, CO

103d • $46 - $48

About The Position

The Investigation Specialist is a technical leader within the MS&T department with a primary role in investigating and documenting calibration, equipment, facility, packaging, or validation failures and deviations from procedures. The role requires a person with industry experience in investigations who will contribute specific compliance knowledge along with investigational and technical writing skills to the Investigations group.

Requirements

• Bachelor's degree preferred; preferably in an engineering or scientific discipline.
• Three or more years of investigation experience.
• Four or more years of experience in a pharmaceutical or regulated industry in quality assurance, production, engineering, or formulation development.
• Strong grasp of Root Cause Analysis and 5 Whys methodology.
• Understanding of ALCOA+ and data integrity principles.
• Proven ability in cross functional groups to solve problems, gain consensus, and drive effective improvement.
• Thorough knowledge of cGMP and application to pharmaceutical manufacturing.
• Basic knowledge of GDP and QA/QC principles and concepts.
• Strong knowledge of word processing, graphics and spreadsheet programs.
• Excellent organizational, interpersonal and leadership skills.
• Strong oral and written communication skills.

Nice To Haves

• Experience with statistical trending and database programs preferred.

Responsibilities

• Assume compliance leadership role in the MS&T Department for management and peers.
• Conduct complex and challenging deviations investigations, lab investigations, and trend investigations requiring a high level of expertise.
• Troubleshoot and take immediate action of quality events in real time with in-depth understanding of product and process impact.
• Create SMART CAPAs and Effectiveness Checks, resulting in the reduction of deviations and recurrences.
• Act as a primary technical resource and point of contact for deviations, lab investigations, and audit activities.
• Maintain a positive atmosphere of teamwork, camaraderie and respect towards co-workers.
• Serve as the departmental point of contact for all EQMS (electronic quality management system) needs in Veeva.
• Interact closely and effectively with project teams and across departments.
• Provide input and guidance as necessary to junior-level technical writers and investigators.
• Assist departmental leadership in new endeavors including efficiency efforts, organizational tasks, and non-routine activities.

Benefits

• Pay range: $46.00 to $48.00 hour depending on experience.
• Equitable, fair pay practices including market-based base pay and a strong benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree