What are the responsibilities and job description for the QA Specialist I position at Thermo Fisher Scientific?
Summary
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, disposition, quality systems and distribution of bulk drug substance.
Essential Functions:
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 requirements of applicable Regulatory Agencies by working collaboratively with one or more of the following areas: manufacturing, testing, batch disposition, quality systems (Discrepancy/Investigation, change control, CAPA), qualification-validation, and distribution of bulk drug substance.
Maintains quality management system associated documentation and all records required to manage the development, production and distribution 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 notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance. Ensure that the products are manufactured in compliance with the regulatory and in a GMP compliant 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.
Administer, document and maintain the company 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 fostering effective interdepartmental and cross functional partnerships.
Support Site Training in 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, as required.
Participate in the execution 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 duties as required.
Education:
To competently perform this job, a candidate will need the education and experience generally obtained with a High School degree and 5-7 years of experience in pharmaceutical, biological manufacturing, or other regulated industry, at least 0-3 years in Quality Assurance or Bachelor's Degree in Technical Sciences or Engineering field with 0-3 years of experience in pharmaceutical, biological manufacturing, or other regulated industry.
Experience:
The preferred level of competency could generally obtained with a Bachelors in Chemistry, Engineering, Life Sciences or related with 0-3 years of experience in pharmaceutical or bio manufacturing.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies:
Strong written and verbal communication skills; change control practices/strategies; Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles; Strong knowledge of GMP, SOPs and quality systems.
Previous experience with identifying, writing evaluating and closing CAPAs and experience with internal and external audit principals preferred.
COMPANY CONFIDENTIAL Page I of2
Physical Requirements:
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk, hear or smell. The employee is occasionally required to walk and stoop, or kneel, crouch. The employee must also occasionally lift and/or move up to 5 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made for persons with disabilities - employee evaluation to determine fitness will be made by company physician(s).
Employee must comply with all applicable safety and security procedures and report potentially unsafe conditions
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
