Senior Specialist 1, Quality Control Instrumentation

Fujifilm•Holly Springs, NC

3d•Onsite

About The Position

The Senior Specialist 1, Quality Control Instrumentation works independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role ensures compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role ensures the performance of routine maintenance, completing periodic reviews of QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role supports stakeholders with issues and guidance related to QC analytical instruments.

Requirements

Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point)
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
Excellent verbal and written communication skills and attention to detail
Thorough understanding of the pharmaceutical/biotech testing
Proven ability to understand and implement data integrity standard and regulations
Proven ability to conduct investigations, writing deviations and CAPA’s
Superior technical writing and problem-solving skills required
The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success
Ability to perform routine on-call and weekend support, as needed
Must be flexible to support 24/7 manufacturing facility
Bachelor’s degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 2+ years of relevant experience OR
Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 0 years of relevant experience
3 years’ relevant experience, experience in a GMP environment
Hands on experience with analytical instrumentation associated with the following technologies: UPLC/HPLC, capillary electrophoresis/imaged capillary isoelectric focusing, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry.

Nice To Haves

Experience with KNEAT software
Experience qualifying analytical instruments
Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.

Responsibilities

Leads the execution of the qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation, applying expertise in instrumentation, validation, and regulatory compliance
Ensures all QC equipment and instruments adhere to regulatory guidelines and site policies
Authors and critically evaluates SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports, employing advanced scientific expertise to ensure accuracy, comprehensiveness, and regulatory alignment
Champions data integrity initiatives related to analytical instruments, deploying specialized analytical skills to safeguard data reliability and compliance
Reviews and recommends appropriate user roles and privileges for data integrity (where applicable), writes instrument operation instructions and preventative maintenance plans
Coordinates with vendors, leveraging scientific insight to ensure effective maintenance and performance of analytical instruments
Completes periodic reviews of QC instruments and associated instrument control software
Proactively identifies and addresses excursions and deviations, initiating effective corrective and preventative actions (CAPAs) using independent judgment to maintain instrument integrity and compliance
Supports stakeholders, including end users, with issues and guidance related to QC analytical instruments
Works cross functionally with all end users, Validation Team, Labware Specialists, and Quality Assurance
Performs other duties, as assigned