Specialist, Quality Control Instrumentation

About the role

The QC Specialist, Instrumentation works under the direction of senior team members to support routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role helps ensure compliance with Data Integrity standards, following regulatory guidelines and company procedures.

Responsibilities

• Supports the qualification, routine operation, maintenance, and decommissioning of QC analytical instruments.
• Ensures QC equipment and instruments adhere to regulatory guidelines and site policies.
• Assists in drafting and reviewing SOPs, technical reports, user requirements, and maintenance documentation.
• Participates in data integrity initiatives related to analytical instruments.
• Helps recommend appropriate user roles and privileges for data integrity and assists in writing operation instructions and preventative maintenance plans.
• Coordinates with vendors for maintenance activities on QC instruments.
• Completes routine periodic reviews of QC instruments and their control software.
• Identifies, reports, and follows up on excursions and deviations and assists in corrective and preventative actions (CAPAs).
• Provides support and guidance to stakeholders, including end users, on QC analytical instrumentation.
• Works cross-functionally with all end users as needed.

Requirements

• Bachelor’s in relevant scientific discipline, preferably Chemistry, Biochemistry, Microbiology, Biology or Life Sciences
• 0-3 years laboratory experience
• Prior 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.

Preferred Qualifications

• GMP laboratory experience
• Experience with Kneat software.
• Experience qualifying analytical instruments

Skills

• 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.

Physical Requirements

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, including distinguishing color.
• Ability to stand for up to 60 minutes.
• Ability to sit for up to 60 minutes.
• Ability to conduct activities using repetitive motions that includes wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than four feet.