(CW) QC Analyst Contract

About the Role

The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing analytical test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines to support further manufacturing of commercial and clinical therapeutics.

This is a contract role.

Shift: Wednesday - Saturday (Onsite 4 days), swing shift (1:00 PM - 11:30 PM)

Key Responsibilities

• Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
• Execute analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
• Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
• Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
• Assist with monitoring and the control of laboratory supply and critical reagent inventories.
• Qualify as a trainer for specified methods, provide training to less experienced staff.
• Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
• Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
• Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
• Identify areas to improve operational excellence by reducing non-value-added activities and increasing process efficiency.
• Perform other responsibilities as deemed necessary.

Requirements & Tech Stack

• Knowledge of:
• Protein determination by A280, Bradford, UV Absorbance
• Enzyme activity
• HPLC/UPLC
• Method validation

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC specific experience is preferred.
• Experience with quality management systems, current Good Manufacturing Practices (cGMP), and QC principles.
• Demonstrated working knowledge with respect to certified functional activities.
• Good documentation, written, and verbal communication skills are essential.
• Must possess the ability to perform most tasks with minimal supervision.
• Computer literacy is required, with proficiency in Microsoft Word and Excel.
• Experience in Microsoft PowerPoint is preferred.
• Familiarity with BINOCS or similar scheduling systems is preferred.
• Familiarity with SAP or similar enterprise systems is preferred.
• Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.