QC Analyst II, Analytical

Roslin CT US Holdings,LLC • Hopkinton, MA

83d

About The Position

The Quality Control Analytical, QC Analyst will be executing analytical methods such as appearance, pH, osmolality, cell counting, ELISAs, flow cytometry and related methods. This position will also provide support to assist the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing. The QC Analyst I/II, Analytical will partner with the analytical team, interface with multiple groups, and must have the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot. He/she will be responsible for authoring Standard Operating Procedures (SOPs), specifications and Test Methods. He/she will assist in the implementation of new assay methodologies and the associated instrumentation. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs.

Requirements

• Bachelor's Degree in scientific discipline.
• 0-5+ years of relevant experience in cGMP Quality Control Laboratory.
• Hands-on experience with various analytical techniques such as pH, osmolality, identifications, ELISAs, cell-based assays, and scientific knowledge in the characterization and transfer of analytical methods.
• Experience with flow cytometry, qPCR, rapid microbiological methods (e.g. mycoplasma) is a plus.
• Knowledge of cGMP/ICH/FDA regulations.
• Ability to independently prioritize/manage activities.
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Proficient in MS Office applications and information technologies that support documentation and data management systems.
• Strong troubleshooting, problem-solving skills, oral and written skills.
• Ability to multi-task and interact with multiple groups in a team-oriented environment.

Responsibilities

• Perform routine and non-routine quality control testing on in-process samples and finished products.
• Operate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP Compliance.
• Provide support for method transfers/qualification/validation and stability testing.
• Support analytical equipment installation and qualification.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Review all data in accordance with applicable procedures and cGMP requirements.
• Author/review SOPs, Test Methods, and other procedures required to operate a QC laboratory.
• Participate in internal and external audits, inspections, investigations, change controls and CAPAs.
• Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function.
• Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
• Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.
• Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Communicate effectively with cross-functional peers, and department management.

Benefits

• Flexible and empowering work environment.
• Attractive benefits package.
• Emphasis on work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees