Associate Quality Control

Associate Quality Control

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

Job Description:

Under minimal supervision, this position will be responsible for activities including microbiology and analytical testing, sample and data management and equipment and instrumentation operation and maintenance in a highly dynamic, team environment. This position will be responsible for one or more of the following activities:

• Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring.
• Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures.
• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks.
• Operate and maintain specialized laboratory equipment and instrumentation.
• Participate in laboratory investigations and audits as necessary.
• Perform general laboratory housekeeping activities.
• Maintain training compliance and proficiency.
• At all times, comply with safety guidelines, cGMPs/CFRs and other applicable regulatory requirements.
• Shift: Needs to be open for either a Saturday – Tuesday and/or a Tuesday – Friday shift schedule.

Top Must-Have Skill Sets:

• Experience with environmental monitoring a huge plus
• Experience with aseptic techniques / sterilizing/ biotech manufacturing highly preferred
• Lab experience, science background, sample handling experience

Day to Day Responsibilities:

Performing water, environmental, and gas sample collection from the clean room manufacturing areas. Incubating and testing environmental samples collected from manufacturing and Quality Control areas, and being able to work within automated sampling systems such as LIMS, LMES, and CIMS.

Preferred Qualifications:

Some previous lab experience is preferred.

Employee Value Proposition:

Career growth/ opportunity

Red Flags:

• Multiple positions within the course of a year or if a staff member only wants to work from home or as an individual contributor - as this is an onsite (USRI) essential position requiring staff to work within a team.
• PhD is very likely overqualified

Interview process:

Phone screening followed by in-person interview.