MCS Associate Quality Control

Job Title:

MCS Associate Quality

Job Description

This onsite role supports a Good Manufacturing Practice (GMP)-regulated laboratory by performing routine analytical testing, maintaining specialized equipment, and ensuring accurate documentation of laboratory activities. The MCS Associate Quality works a standard Monday-Friday schedule from 8:00 AM to 5:00 PM and contributes directly to reliable, compliant laboratory operations. The position is ideal for a candidate with a bachelor's degree in a scientific discipline and prior academic or industry laboratory experience who is comfortable working with basic lab techniques and electronic systems.

Responsibilities

+ Perform routine laboratory procedures and analytical testing in a GMP-regulated environment across multiple methods, including assays such as ELISA after training.

+ Execute basic laboratory techniques such as pipetting, including multichannel pipetting, weighing, calculations, and preparation of dilutions.

+ Document, compute, compile, interpret, and enter data accurately into lab notebooks and electronic systems in accordance with good documentation practices.

+ Maintain and operate specialized laboratory equipment, ensuring proper setup, calibration, routine maintenance, and troubleshooting as needed.

+ Support laboratory inventory management by monitoring supplies, reagents, and consumables and ensuring availability for daily testing activities.

+ Maintain laboratory logbooks and other controlled records in compliance with cGMPs, CFRs, and internal procedures.

+ Initiate and implement changes in controlled documents under general supervision, following established change control processes.

+ Adhere to regulatory requirements, written procedures, and safety guidelines, including the maintenance of training records and building monitoring systems.

+ Evaluate documentation and data according to company and regulatory guidelines, identifying discrepancies or issues and escalating appropriately.

+ Contribute to continuous improvement by identifying, recommending, and potentially implementing improvements related to routine job functions.

+ Organize daily workload, handle multiple priorities, and meet testing and documentation deadlines in a fast-paced laboratory environment.

+ Learn and consistently comply with safety guidelines and cGMPs, including proper handling of materials, equipment, and laboratory spaces.

+ Collaborate and communicate effectively with colleagues and supervisors to ensure smooth laboratory operations and timely completion of testing.

Essential Skills

+ Bachelor's degree in a scientific discipline.

+ Prior academic or industry laboratory experience.

+ Proficiency with basic laboratory techniques, including pipetting, weighing, calculations, and preparation of dilutions.

+ Comfort working in a GMP-regulated environment and performing routine GMP testing across multiple methods.

+ Ability to adhere to regulatory requirements, written procedures, and safety guidelines, including cGMPs and CFRs.

+ Strong attention to detail and good documentation practices for both paper-based and electronic records.

+ Experience using lab notebooks and electronic systems for data entry and documentation.

+ Ability to evaluate documentation and data according to company and regulatory guidelines.

+ Strong written and oral communication skills for clear documentation and effective collaboration.

+ Ability to organize work, handle multiple priorities, and meet deadlines.

+ Flexibility and adaptability to changing priorities and requirements.

+ Demonstrated understanding of regulatory requirements, safety guidelines, and factors impacting compliance.

+ Ability to recognize when and how to appropriately escalate issues or concerns.

+ Problem-solving skills…