QC Technician II

We are hiring a Quality Control Technician II. The Quality Control Technician II will perform applicable testing on raw, in-process, and final products to ensure material quality as well as to perform tests for monitoring environmental conditions and water quality.

• Independently Review and Report Data
• Documentation of all final products (Product Quality Control Profiles and management of data)
• Draft and execute validation reports for analytical method utilized for the determination of final product quality status
• Perform microbiology and/or biochemical assay qualification and routine testing
• Environmental monitoring of utilities and classified rooms/spaces to support new utility and facility qualifications
• Monitor and maintain QC Laboratory equipment and process validation status.
• Preparation of buffers, general lab support and ordering lab supplies as needed
• Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning
• Present ongoing assay data summaries with recommended pathways forward.
• Testing on raw, in-process and finished product
• Testing on environmental conditions to monitor regulated areas.
• Testing on the water systems to ensure water quality is maintained
• Calibration and maintenance of instrumentation and methods as necessary
• Test material to investigate customer difficulties
• Maintain and record data clearly and precisely
• Modification of standard operating procedures as necessary
• In process (WIP) material testing and handling under aseptic conditions
• Support the production departments as needed

• Bachelor’s degree, two – three years in pharmaceutical, or biotech lab environments
• Knowledge of working in a GLP, cGMP environment
• Knowledge of laboratory operations
• General knowledge of computer systems and productivity software
• Good lab safety
• Basic understanding of 21CFR211 – cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD- 93/42 with emphasis on laboratory testing, material specifications, and related areas
• Ability to speak, write and read English fluently
• Good oral and written communication skills

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 per essential functions.

• While performing the duties of this job, the employee is frequently required to stand. The employee is occasionally required to walk, sit, use hands to handle, feel or reach with hands and arms; climb or balance; and talk or hear. The employee must occasionally lift and/or move up to 15 pounds.
• Specific vision abilities required by this job include close vision, and depth perception.
• Must be capable of a minimal amount of air travel.

The work environment characteristics described here are representative of those an employee encounters18 while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Employee must be familiar with, implement and observe the SOPs related to working in the laboratory and manufacturing environments.
• Laboratory environments frequently require wearing provided eye protection and lab coats.
• The employee may be required to enter manufacturing areas where higher noise levels may necessitate wearing provided ear and eye protection.
• Controlled environments in manufacturing may require wearing provided head covering, gloves and lab coats or clean room garments. Additionally, respiratory protection may be required in powder manufacturing areas.
• Scientific research projects may require occasional weekend work.

#LI-AA1

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.  For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms’/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms’/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.