MCS Associate Quality Control

Job Opportunity

Duration: 12 months Contract 100% onsite Monday–Friday, 8:00 AM–5:00 PM Overtime: Occasional; ~once a month on a weekend (usually 1 day)

Description:

Ideal candidate has a Bachelor's degree in Life Sciences (Biology, Chemistry, Biochemistry) and has lab and GMP experience in a regulated environment, preferably within pharma, biotech, or academia. Must possess hands-on experience in analytical testing, including cell-based potency assays and ligand-binding assays (e.g., ELISA), with demonstrated proficiency in core laboratory techniques such as pipetting, preparation of serial dilutions, and use of automated liquid handling systems in a regulated QC environment. Along with basic Excel and Word proficiency for data entry in lab notebooks and electronic systems. Soft skills include strong communication, conflict resolution within a small team, and self-starting initiative.

Job Details:

• Under general supervision, this position will perform routine procedures and testing in support of the lab.
• This position will be responsible for one or more of the following activities:
• Performing routine laboratory procedures
• Routine analytical testing
• Documenting, computing, compiling, interpreting, and entering data
• Maintaining and operating specialized equipment
• Initiating and / or implementing changes in controlled documents. Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.

Preferred Qualifications:

• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to organize work, handle multiple priorities and meet deadlines
• Strong written and oral communication skills
• Must be detail orientated
• Must be flexible and adaptable to changing priorities and requirements
• Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
• Demonstrates understanding of when and how to appropriately escalate.
• May identify, recommend and implement improvements related to routine job functions.
• Must learn and comply with safety guideline and cGMPs.
• Basic Qualifications
• High school/GED and 2 years work or military experience OR Associates and 6 months work or military experience

Top 3 Must Have Skill Sets:

• Proficiency in core laboratory techniques, including accurate pipetting, preparation of serial dilutions, and general assay setup.
• Working knowledge of QC/GMP practices, including proper documentation, data integrity, and adherence to standard operating procedures (SOPs).
• General understanding or hands on experience executing cell-based assays and/or ligand-binding assays in a laboratory setting.

Day to Day Responsibilities:

• Execute cell-based potency assays and ligand-binding assays (e.g., ELISA) to support release and characterization testing of drug substance and drug product.
• Perform routine bioassay testing in support of stability studies, including sample preparation, assay execution, and data analysis.
• Accurately document test results in accordance with GMP requirements, ensuring data integrity and compliance with established SOPs.
• Prepare reagents, standards, and controls, including performing precise pipetting and serial dilutions required for assay execution.
• Maintain and monitor cell cultures to support cell-based assays, ensuring cell health and assay readiness.
• Operate and maintain laboratory equipment, including plate readers and automated liquid handling systems.
• Manage inventory of critical reagents, reference standards, and laboratory supplies; coordinate ordering and ensure material availability.
• Support assay troubleshooting, investigations, and continuous improvement initiatives as needed.
• Collaborate with cross-functional teams to ensure timely completion of testing to meet production and stability timelines.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"