The Quality Assurance (QA) Associate Analyst – Manufacturing Support, under direct supervision, will be responsible for assisting with the review and/or approval of basic documentation; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements; Review of manufacturing documents such as Batch Records, Cleaning forms/records, Logbooks; Perform cleaning verification or other similar inspections of manufacturing rooms and support areas; Other activities as directed by the direct Supervisor.
- Support/execute QA on the Floor program.
- Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise.
- Assist with review of basic documentation to include, but not limited to:
- Standard Operating Procedures
- Batch Records
- Assist with inspection of final product containers and review and/or approval of executed process records and data.
- Assist in Quality audits to include, but not limited to:
- Audit of lab notebooks
- Audit of equipment logbooks
- Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- All other duties as needed.
Required Skills & Abilities:
- Excellent written and oral communication skills
- Excellent organizational, analytical, data review and report writing skills
- Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly
- Proficient in Microsoft Office
- All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, some bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Lifting up to 25 pounds on occasion.
- Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.
- Attendance is mandatory.
- Associates degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field; OR
- High School Diploma/GED with some previous work experience.
- ASQ Certification
- Knowledge of GMP/GLP regulations
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.
If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.