Quality Control Analyst I
LGC · Milford, MA · 2 wk ago
On-siteQuality Assurance$26/hrFull-time
About the role
The Quality Control Analyst I position focuses on the characterization of biological materials and provides support to manufacturing with timely and accurate in-process and final product testing. Key areas of responsibility include routine testing, data analysis, clean room environmental monitoring, equipment calibration, preventative maintenance, and documentation.
Responsibilities
- Accurately perform routine testing with ELISA, immunoassays, bioburden, Western Blot, endotoxin, and sterility testing, and other test methods on infectious and non-infectious raw material samples and finished biological products.
- Analyze and record testing data with a focus on accuracy, ensuring timely work impacts other groups to meet critical customer deadlines.
- Perform routine clean room environmental monitoring and water system sampling.
- Ensure testing equipment is calibrated prior to use.
- Perform weekly and monthly preventative maintenance to ensure equipment is working properly.
- Maintain an accurate electronic database of sample submission, testing, and final disposition.
- Produce and use control charts. Perform tracking and trend analysis on laboratory data.
- Performs quality control duties including, but not limited to; daily temperature log entries, emptying biohazard trash, etc.
- Document technical problems, report problems to Supervisor.
- Adhere to company Standard Operating Procedures, as well as, regulatory agencies and customer requirements.
- Comply with cGMP and ISO standards at all times to support LGC’s commitment to Quality.
- Aid in the implementation of corrective actions in response to internal and external audits.
- Maintain the appearance of the QC lab on a daily basis for audit readiness.
- Follow Operational Excellence principles, e.g., removal and disposal of expired chemicals and reagents, removal of broken equipment and unused equipment and supplies from the laboratory.
- Perform other duties as required, or assigned by management, to meet business needs.
Qualifications
- Minimum Qualifications: Bachelor’s degree in science or related field with 1-2 years related experience
- An understanding of immunoassays is required.
- Ability to work on problems of simple scope where analysis of situations or data requires a review of a variety of factors.
- Excellent verbal and written communication skills in English are essential, including the ability to communicate technical problems in a clear, concise manner.
- Action oriented, able to take initiative to perform routine tasks without being asked.
- Experience with Microsoft Software (Word, Excel, Office).
- Basic mathematical skills are required.
- Good organizational skills
- Sharp attention to detail
- Must be a positive team player with excellent interpersonal skills.
Preferred Qualifications
- Skilled in performing ELISA’s is desirable.
- Previous experience with automated chemistry analyzers and immunoanalyzers is desirable.
- Previous experience in a regulated laboratory setting is desirable.
Competencies & Behaviors
- Resonate and operate in line with LGC’s core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect
- Continuous learner, always seeking opportunities to learn how to perform new assays.
- Adaptable, with the capacity/flexibility to respond to the demands of a growing/changing company.
- Complete the existing workload under supervision.
- Communicate & collaborate across teams for day-to-day activities.
- Possess a strong work ethic
- Performance driven
Additional Information
The customary salary range for this position is:
- Minimum pay rate: $26.00 USD per hour
- Maximum pay rate: $39.00 USD per hour