Under general supervision, provide comprehensive manufacturing technical support and quality assurance oversight to meet good business practices and the requirements of applicable regulatory agencies, supporting one of the following areas: API manufacturing, testing, batch disposition, quality systems, and distribution of bulk drug substance.

Apply technical knowledge to address a broad range of issues to ensure adherence to and compliance with established company policies and procedures, as well as applicable Regulatory requirements by working together with one or more of the following areas: manufacturing, testing, batch disposition, quality systems (Discrepancy/Investigation, change control, CAPA), qualification-validation, and distribution of drug substances.

Maintain quality management system-associated documentation and all records required to coordinate the development, production, and release of the products manufactured at this facility.

Provide direct support to archival and retrieval of documentation and/or drawings to and from approved storage areas.

Provide support in the monitoring and analyzing of business process performance measures and inform management of potential quality or compliance issues that may affect product quality or regulatory compliance.

Ensure that the products are manufactured in compliance with the regulations and in a GMP manner by reviewing batch records and performing appropriate investigations.

Provide Quality Assurance support to resolving raw material, in-process material, bulk and final product, environmental, and system issues.

Assist in writing and revising site SOPs or other procedures as required.

Coordinate, document, and maintain the company's Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of the company’s Quality Systems and tools, as well as direct actions.

Troubleshoot and direct the resolution of Quality issues by encouraging effective interdepartmental and cross-functional partnerships.

Support Site Training in the development, delivery, and maintenance of Quality training programs (e.g., CAPA process, GMP, etc.).

Participate in audits and inspections performed by clients and regulatory agencies.

Assist in the implementation and/or administration of corporate Quality System tools such as TrackWise, Documentum, EDMS, etc.

Provide input to the development of personal performance goals and departmental objectives; collaborate with Management to establish and meet targets and timelines.

Participate in the design and implementation of department and cross-functional initiatives.

Maintain a state of inspection readiness.

Perform other assignments, as required.

To competently perform this job, a candidate will need the education and experience generally acquired with a BS degree in Chemistry, Biology, or a related scientific subject area; will consider an Associate's Degree (AA/AS) with two to four years of meaningful experience. Previous Pharmaceutical or cGMP experience preferred

The preferred level of proficiency could generally be acquired with a Bachelor in Chemistry, Engineering, or Life Sciences or related with 2-4 years of experience in pharmaceutical or biomanufacturing.

Equivalent combinations of education, training and relevant work experience may be considered.

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $45 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 110,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.