Biologics QC Analyst - cGMP Lab, Fast-Paced

Artech LLC.; Harvard (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading IT staffing company is seeking a Quality Control Analyst for a 6-month contract in a cGMP laboratory. The ideal candidate will have a B.S. in chemical sciences and at least 2 years of experience in a Biologics QC lab. Responsibilities include performing bioassays, cell passaging, and data review. Strong communication skills and proficiency in cGMP regulations are essential. This role may include weekend assignments, offering a dynamic working environment.

Qualifications

• A minimum of 2 years’ experience in Biologics QC laboratory.
• Proficiency in applying cGMP regulations required.
• Demonstrated ability to work independently and as part of a team.

Responsibilities

• Perform bioassay routinely in a fast paced environment.
• Conduct cell passaging utilizing aseptic technique.
• Perform routine testing and data review of bulk drug substance.

Skills

Communication skills

Technical skills

Cell passaging techniques

Data review

Education

B.S. in chemical sciences or related discipline

Tools

LIMS

Excel

Electronic data collection

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Title: Quality Control Analyst

Duration: 6 Months(extension up to 3 year)

Job Description:

QC Operations Bioassay analyst needed. Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE). Work may include weekend assignments.

Performs bioassay routinely in a fast paced environment.
Cell passaging utilizing aseptic technique.
Routine testing and data review of batch release and stability samples of Bulk Drug Substance and Drug product in a cGMP compliant environment.
Excellent communication skills, both written and verbal
Excellent technical skills, LIMS, Excel, electronic data collection.

Qualifications

Qualifications:
Knowledge of science generally attained through studies resulting in a B.S. in chemical sciences, a related discipline, or its equivalent.
A minimum of 2 years’ experience in Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
Proficiency (or mastery) of Cell passaging techniques preferable with automation (1 year).
Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
Proficiency in applying cGMP regulations and compendial testing required.

Additional Information

For more information, Please contact

Artech information Systems LLC

360 Mt. Kemble Avenue, Suite 2000 Morristown, NJ 07960

973.967.3384

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