MCS Associate Quality Control

MCS Associate Quality Control

3 Key Consulting is hiring a MCS Associate Quality Control for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

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.

Basic Qualifications:

• Bachelor's degree and 2 years of Quality Control, Quality Assurance or related experience
• OR
• Associate's degree and 6 years of Quality Control, Quality Assurance or related experience
• OR
• High school diploma / GED and 8 years of Quality Control, Quality Assurance or related experience

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.

Why is the Position Open?

Supplement additional workload on team.

Top Must-Have Skill Sets:

• Pipetting
• Aseptic
• Documentation

Day to Day Responsibilities:

This Associate, in the Bioassay group, within client's quality control organization will work in a dynamic team environment to support testing, and projects within the group. The successful candidate will be responsible for Bioassay lab activities including analytical testing and analysis, tracking and trending of data, lab cleaning, and equipment maintenance. Responsibilities:

• • Testing
  • Execute routine and non-routine testing procedures and assays
  • Perform data analysis of testing results and communicate results to appropriate sources
  • Comply with safety guidelines
  • Learn and comply with GLP, and cGMPs, which includes, but are not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory logbooks.
• • Material/Data Management
  • Responsible for documenting, computing, compiling, interpreting, and entering data
  • Responsible for the inventory management of all media, and reagents
  • Ensure the timely disposal of tested samples.

Employee Value Proposition:

The person in this role will work with 22 different molecules. You will be very hands on and see medicines go to patients. This position has great opportunities for growth.

Red Flags:

• Non-science degree
• No lab experience

Interview process:

Phone screening followed by in-person interview.