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

Description

Purpose and Scope

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.

Essential Duties & Responsibilities

• Assume compliance leadership role in the MS&T Department for management and peers. Includes dissemination of specific knowledge to the MS&T group and technical leadership in Deviation and Laboratory Investigation Quality Events.
• Conduct complex and challenging deviations investigations, lab investigations, and trend investigations requiring a high level of expertise and in-depth knowledge of work performed at Tolmar.
• 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.
• Accountable for maintaining 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 that require a higher level of technical, organizational, and project management skills.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

Core Values

This position is expected to operate within the framework of Tolmar's Core Values :

Education & Experience

Working Conditions

Working conditions are typical for an office environment.

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Qualifications

Education

Bachelors of Science (required)

Experience

4 years : 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.

Experience with statistical trending and database programs preferred. (required)

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.