Operations Specialist III

Operations Specialist III

Assists in ensuring that the site complies with all pertinent HSE regulations, permits, statutes, local ordinances and/or other externally driven requirements.

Assists in ensuring that the site complies with applicable regulations as well as all pertinent Client Global HSE policies and procedures.

Provides HSE services to the site in an effective and efficient manner.

Provides assistance to the site's primary point of contact on HSE issues for regulatory authorities.

Supports the development and maintenance of an effective and efficient HSE Management System and provides assistance for some of the supporting programs (e.g. Chemical Safety, Biosafety, Radiation Safety, Industrial Hygiene, Environmental Compliance, Occupational Health, Client Crisis Management (ACM)) that are appropriate in consideration of the site's complexity, population, regulatory burden/environment, criticality and location.

Supports incident response procedures.

Supports the risk management program for the site (e.g. Risk Register development and review), Client Crisis Management

Key Performance Indicators:

• Assigned documents, programs and systems meet externally-driven compliance requirements as assessed by the appropriate external agencies during inspections, report reviews, analytical data reviews, or as assessed by 3rd party or internal compliance audits.
• Assigned portions of the Global HSE procedures are fully implemented, as assessed by internal audit.
• All site HSE indicators or programmatic goals/targets are achieved within agreed-upon timelines.
• Site HSE Officer, site customers, Global HSE, and Global HSE Business Partner satisfaction with HSE program and service effectiveness and timeliness at the respective site.
• Applicable audit-generated action items or agency-generated findings are closed within the agreed-upon timelines and in a manner which prevents recurrence.
• Assigned reports required by external agencies and by Client internal data collection processes, are completed in a thorough manner and within agreed upon timelines.

Education:

• Certificate and/or 1-to-2-year college / university degree in safety management, industrial hygiene, environmental science, occupational health and/or medicine, engineering, or related field.
• Depending on the country, technical apprenticeship or certifications may be acceptable as min. educational requirement.

Experience:

• At least 3 years of professional experience related to HSE but may be a recent college/university graduate with experience limited to internships or similar.

Language:

• The ability to fluently read, write, understand, and communicate in English.
• Knowledge of the following regulations and standards: ISO13485, MDSAP, EU MDR/MDD, and Good Manufacturing Practices (GMP).

EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."