Job description

Position: Technical Operations Contractor - II (Associate)
Location: Elkton, VA
Duration: 12 Months

Responsibilities:

• End to End raw material and single use component support; including material selection, qualification, material build into Client systems, supplier complaint support, and continuous improvement.
• Creation, qualification, and commercial use implementation of new raw material and single use technology supply chains
• Extension of raw material supply chains and single use technology materials from other commercial and development products
• Qualification of single use technology for compatibility, biocompatibility, extractables and other process suitability characteristics
• Interaction with suppliers and using areas to manage design and suitability of single use technology
• Management of change elements supporting new and extended raw material supply chains and single use devices
• Ongoing interaction with local and extended network (US, EU) manufacturing, development organizations, communities of practice, and centers of excellence for the selection and deployment of single use technology.
• Design and execution of continuous improvement projects in support of these responsibilities, including procedure and form management

Education Minimum Requirement:

• A bachelor's degree in science, engineering or equivalent discipline with 1-2 years' experience in a cGMP environment (technical, and/or quality)

Required Experience and Skills:

• Chemistry knowledge to differentiate between chemical substance properties, storage conditions and differences in quality grades
• Raw material and/or single use component qualification knowledge
• Knowledge of compendial differences and requirements for raw materials and single use components
• GMP compliant documentation practices and data integrity

Preferred Experience and Skills:

• Experience with SAP® software (navigation and data review / extraction)
• Ability to clearly communicate requirements and expectations with stakeholders with varied technical and non-technical backgrounds (business, quality, engineering, manufacturing, supply chain, production systems and compliance frameworks)
• Understanding of supply chain assessments and evaluation processes
• Supplier relationship / point of contact experience
• Change management within a cGMP environment

The successful candidate must have:

• Materials knowledge in support of the position responsibilities (compatibility, extractables, general chemistry)
• Strong verbal and written communication skills, team skills, personal character, and ethics
• Strong problem-solving skills and a hands-on approach to problem solving.
• Enthusiasm, confidence, and initiative-taking ability needed for continuous learning and its applications.
• Strong desire to succeed and to help others to do the same.
• Experience with component and material builds, within an SAP® environment is preferred but not required
• Supplier relationship experience is preferred.

Comments/Special Instructions

• Candidate info- Good mix of both Technical and customer service/focus.
• Biochemist/Chemist Engineer background preferable.
• Someone who can work autonomously, not afraid to ask questions, self-motivated
• Summary-Bringing in raw and single use materials to support production areas.
• Following SOPs, reaching out to suppliers and assisting with supplier compliants, confirming with IPT the actual "need ", gather documentation (fit for use), route through approvers (MIDAS), enter into client's systems.

Job Types: Full-time, Contract

Salary: Up to $43.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Elkton, VA 22827: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• cGMP: 1 year (Required)
• Chemistry: 1 year (Required)
• raw materials: 1 year (Required)
• SAP: 1 year (Required)
• Change management: 1 year (Required)

Work Location: One location

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