| Job Description | Expectations for All Employees:
Employees are required to support the organization’s quality policy and quality objectives by exhibiting the following behaviors on the job: competence, collaboration, integrity, innovation, respect, commitment, accountability, and ownership. All employees are expected to take responsibility for maintaining company quality standards and to notify management if additional training is needed to meet the position requirements and/or to stay current with job standards and competencies needed.
Position Summary:
Assist the Director of QA / Regulatory Affairs in ensuring compliance of sites with the necessary regulatory standards including applicable permitting, waste management, inspections, environmental reporting, EH&S review of processes, equipment and documents. Responsible for supervising and/or executing MSDS creation and label hazard assignment and label review. Assists with determination of product shipping hazards under DOT and IATA regulations and maintains information distributed internally for shipping hazards. Manages staff in the EH&S department who are ensuring compliance to all applicable regulations including EPA, OSHA, DOT, etc.
Primary Duties and Responsibilities:
Oversees site waste management including inventories and waste removal.
Oversees applicable permits (obtaining and maintaining) to ensure compliance with regulations.
Responsible for completing and/or overseeing applicable environmental reporting.
Coordinates incident reports and investigations.
Maintains emergency / contingency plans.
Provides or oversees technical guidance on hazards for new processes, equipment and process documents.
Creates, updates or oversees these activities for product MSDSs on a routine basis to comply with US and world-wide regulations.
Assists in assigning hazards for product labels and in reviewing new or revised labels for approval prior to use.
Oversees the performance of safety inspections of equipment, including fire extinguishers, exit signs, emergency lights, first aid kits, eyewashes, safety showers, etc
Audits written regulatory programs for compliance against appropriate standards. Audits the practiced programs to ensure compliance with written programs.
Maintains and oversees the Hazard Communication and Chemical Hygiene Plans for the Cleveland and Maumee sites. Audits these plans annually and provides training as needed. Assists as needed with other safety / regulatory training of employees at both sites.
Manages monthly Safety Committee Meetings. Ensures minutes are taken and distributed.
Manages and assists with determination of product shipping hazards under DOT and IATA regulations and maintains information distributed internally for shipping hazards.
Education:
Bachelors degree in related science field (i.e. Biology, Chemistry, Env. etc.) required or equivalent experience in chemical / reagent or pharma manufacturing area).
Bachelor degree
Yrs. of related experience:
3 yrs
5 to 7 years
Competencies
(skills, knowledge, abilities)
Strong team work and communication
Working knowledge of Federal and Ohio EH&S regulations including EPA, RCRA, OSHA, etc.
Strong analytical and decision-making skills with the ability to follow verbal/written instructions. Ability to thoroughly document all activities performed.
Skilled in the use of word processing, spreadsheet, and database software.
Working knowledge of EU directives a plus (e.g. REACH)
Working knowledge of DOT and IATA regulations a plus.
QSR and ISO 13485:2003 training |
| | Company | | Affymetrix | Job Code | | State or Province | | Ohio | | |
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