Quality Control Analyst

True Title: QC Analyst II – Biochemistry

6 Months

Lexington, MA

Job Summary

Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.

Job Responsibilities

• Specific Biochemistry Focus Areas:
• Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., in order to support in-process, release and stability testing.
• Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.
• Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
• 40-50% Testing execution, participate in training analysts, trouble shooting of methods
• 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
• 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support

Education & Qualifications

• Typically requires a bachelor’s degree and a minimum of 5 years of related experience. (science related degree is preferred)
• Excellent communication, interpersonal and organizational skills.
• Ability to work well both independently and in a team environment.
• Ability to prioritize work and multitask.
• Previous experience in a GMP QC role is preferred
• Key Skills, Abilities, and Competencies
• Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices. Position requires critical thinking.
• Key Skills: MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding
• Limited to no travel expected. Travel between sites is required.
• The following physical abilities are required in order to fulfill the job duties:
• Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
• Ability to work around chemicals (if working around the laboratories)
• Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
• Ability to walk and stand for periods of time
• Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours