QC Analyst- Analytical Chemistry

Position: QC Analyst
- Analytical Chemistry

Length: 12 Month Contract

Required Shift: Friday-Monday, 4x10-hour shifts

Job Description:

The QC Analyst - Analytical Chemistry will independently execute and review routine in-process, drug substance, stability, facility monitoring, environmental monitoring, and critical utility testing in a cGMP-regulated laboratory environment. This role will use laboratory instrumentation and computer systems to collect, review, and record data while supporting laboratory operations, quality system events, investigations, and continuous improvement activities.

Essential Duties and Responsibilities:

• Execute and review routine in-process, drug substance, stability, environmental monitoring, and critical utility test methods in a timely manner.
• Use laboratory instrumentation and computer systems such as LIMS, Softmax Pro, Charles River Endoscan, MODA, and Empower to collect and record data.
• Maintain laboratory operations, including cleaning, supply ordering, reagent preparation, stocking, and waste disposal.
• Demonstrate functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures.
• Work in a laboratory environment for extended periods while conducting testing, reviewing data, maintaining materials and instruments, and supporting other laboratory functions.
• Complete routine testing, special project testing, and protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with SOPs, specifications, and cGMP regulations.
• Exercise independent judgment within defined QC procedures and practices to troubleshoot problems and formulate solutions.
• Initiate and own laboratory investigations, low- and medium-risk deviations, CAPAs, and change controls of moderate scope within an electronic Quality Management System.
• Participate in cross-functional teams.
• Draft studies and investigations of moderate scope and work on problems requiring review of identifiable factors.
• Author new SOPs and initiate changes to existing procedures.
• Train new QC Analysts on routine procedures and practices.
• Perform equipment maintenance and calibrations as required.
• Complete mandatory training within required time frames.

Qualifications:

• Bachelor’s or master’s degree in Life Sciences with relevant laboratory coursework.
• 3-6 years of relevant experience preferred.
• QC analytical skill set including HPLC, UPLC, appearance, concentration, pH, capillary electrophoresis, osmolality, TOC, and strong micropipetting skills.
• Previous experience in a regulated environment preferred.
• Understanding of laboratory instrumentation required.
• Knowledge of cGMP manufacturing.
• Knowledge of chemical, biological, and/or microbiological safety procedures.
• Ability to communicate effectively with managers and peers.
• Ability to read, write, and converse in English.
• Basic computer skills, including general use of word processing, spreadsheets, databases, training systems, performance management tools, and self-service systems.
• Good interpersonal skills with the ability to work effectively and efficiently in a team environment.
• Eagerness to learn and continuously improve.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.