Materials Regulatory Compliance Specialist

1 week ago

Smithfield, United States High Purity New England Full time

The Materials Regulatory Compliance Specialist (MRCS) is responsible for ensuring compliance with applicable regulations, industry standards, and HPNE internal policies/procedures. The MRCS manages administrative communications with suppliers and customers regarding compliance of materials, provides technical review of documentation and reports, and implements necessary process and documentation changes. This position works cross-functionally in collaboration with engineering, materials management, and supplier quality.

Supervisory Responsibilities:

  • None
Duties/Responsibilities:

Your responsibilities as a Materials Regulatory Compliance Specialist will include but not limited to:
  • Own the Raw Material Compliance Program including, but not limited to, new raw material requests, risk assessments, and material qualification.
  • Manage all processes and documentation of materials as it pertains to regulatory compliance including but not limited to REACH, RoHS, BSE/TSE, USP Pharmacopeia, Proposition 65, Conflict Minerals, etc.
  • Manage the responses to all materials related customer questionnaires and documentation requests
  • Collaborate cross-functionally to build a detailed catalog of approved components for single-use assemblies including relevant supporting test data to document compliance to relevant industry standards.
  • Participate in the Change Control Board and Design Review Team
  • Lead the cross-functional development of raw material specifications to ensure critical materials meet customer requirements
  • Provide support for Deviations, Change Controls, and New Product development as it pertains to the qualification of raw materials; support internal audits of cGMP systems and facilities.
  • Stay current with industry trends and regulatory requirements related to raw materials, providing guidance and recommendations to internal stakeholders.
  • Other projects and duties as assigned for the overall benefit of the organization
Required Skills and Abilities:
  • Ability to absorb and apply new information quickly and effectively
  • Strong interpersonal, oral, and written communication skills
  • Facilitation skills, particularly across functions
  • Strong self-initiative and the ability to work independently to achieve results
  • Strong problem-solving and risk-based decision-making abilities
  • Strong grasp of manufacturing systems and processes
  • Excellent organizational skills and attention to detail
Education and Experience:
  • Bachelor's degree in Science or Engineering discipline, or equivalent combination of education and experience required.
  • Minimum of 5 years of experience in Quality, Manufacturing or related field in an FDA regulated, GMP manufacturing environment (preference give to pharmaceutical industry).
  • Demonstrated knowledge of current Good Manufacturing Practices (cGMP).
  • Experience with ISO 9001 quality management systems (QMS).
  • Experience writing standard operating procedures, protocols, reports, and deviations preferred.
  • ERP experience preferred.
  • Proficient with Microsoft Office Suite.
  • Cleanroom experience preferred.

Physical Requirements:

Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level. Although this position primarily works in an office environment, while performing the duties of this job, the position can be exposed to a warehouse environment where there are vehicles and a noise level in the work environment can be loud.

Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 30 lbs.

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