Research Associate, QC Microbiology

Job title: Quality Control Analyst

Job Location: Brooklyn Park MN 55445

Job Duration: 12 + months Contract

Pay Rate- 33/hr. on W2

Job Description

• Independently executes and reviews routine in-process, drug substance, and stability test methods in a timely manner.
• Uses a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower).
• Maintains lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).
• Conducts test methods, including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability.
• Owns and authors quality system events (i.e., laboratory investigations, deviations, CAPAs, and change controls).

Responsibilities: Job Function and Description

• Demonstrates a functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures (SOPs).
• Works within a laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments, and other laboratory functions as required.
• Completes all testing, including special project and protocol testing, in a timely and appropriate manner.
• Maintains data integrity and ensures compliance with company SOPs, specifications, and cGMP regulations.
• Independently exercises judgment within generally defined Quality Control (QC) procedures and practices in selecting methods and techniques to troubleshoot problems and formulate solutions.
• Makes decisions that have moderate impact on future QC processes and procedures that affect batch disposition.
• Initiates and owns laboratory investigations, basic complexity low and medium-risk deviations, CAPAs, and change controls of moderate scope within the electronic Quality Management System.
• Participates in cross-functional teams.
• Drafts studies and investigations of moderate scope and works on problems where the situation or data requires a review of identifiable factors.
• Authors new SOPs and initiates changes to existing procedures.
• Trains new QC Analysts on routine procedures and practices.
• May be required to work overtime or be assigned to a different shift as needed.
• Performs equipment maintenance and calibrations as required.
• Completes mandatory training within the required timeframe.
• Performs other duties as assigned.

Education and Experience Requirements

• Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework.
• 3–6 years of relevant experience preferred.
• Previous experience in a regulated environment preferred.
• Must understand laboratory instrumentation.
• Must be able to communicate effectively with managers and peers.
• Must be able to read, write, and converse in English.
• Must have basic computer skills. General use of word processing, spreadsheets, databases, etc., for the purposes of work execution, training, performance management, and self-service.
• Good interpersonal skills and able to work effectively and efficiently in a team environment.
• Knowledge of cGMP manufacturing.
• Knowledge of chemical, biological, and microbiological safety procedures.
• Must display eagerness to learn and continuously improve.

Key Skills, Abilities, and Competencies

Additional skills include, but are not limited to:

• QC Micro Skill Set – contamination control, endotoxin, bioburden, environmental monitoring, manufacturing cleanrooms, aseptic technique, critical utility systems.

Complexity and Problem Solving

• Employee at this level is involved in routine tasks of moderate scope and complexity.
• Employee receives instructions on new work and refers to policies and procedures for guidance.
• Responsible for conducting independent work with minimal guidance from trainers and senior staff.
• Responsible for contributing to moderate-scope decisions founded on sound principles, international industry and regulatory standards, and robust scientific basis.
• Understands the needs of key collaborators (i.e., Manufacturing Operations, Quality Assurance, Validation, and Quality Systems) to provide compliant and timely test results.

Internal and External Contacts

• Participates in cross-functional collaboration with internal departments (i.e., Quality, Manufacturing, Engineering, Metrology, and Business Excellence).