Quality Control Analyst

Position Title: QC Analyst 1
Site Location: 100% ONSITE - Lexington, MA

Primary duties of this position will focus on the daily lab operations and execution
of testing to support manufacturing operations. Testing may include but not limited to
samples from drug substance and drug product, manufacturing, stability, raw materials
and various protocol studies using test methods. The assays range from pH, enzyme
concentration to more complex assays such as SDS silver Gels, PCR, DNA and enzyme
activity. This position is expected to maintain operational and GMP readiness of the QC
areas. In addition, this position will participate in more complex projects, Operational
excellence initiatives and various quality systems.

Discretion: Work is closely supervised. Follow specific, detailed instructions
Impact: Contributions are usually limited to task-related activities. Errors do not typically have
major effect on the organization
Specific QC Focus Area:
Biochemistry Focus: A280, SOLO A280, Compedia methods (pH. Moisture, OSMO,
Appearance, Subvisible particles), Enzyme Actitity assays, DNA, PCR, Free Thiol

Responsibilities: Job Function and Description
% of Time Job Function and description
80% Testing execution
10% QC operations support which entails data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab housekeeping, support for other QC groups if needed.
10% Compliance and quality systems (SOP revisions, input to quality system

Education and Experience Requirements
Essential: Bachelor's degree and minimum of 0-2 years related experience
Desired: GMP knowledge, work experience

Key Skills, Abilities, and Competencies
Limited use and/or application of basic principles, theories and
concepts. Limited knowledge of industry practices and standards. Position requires
critical thinking.
Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science
understanding
Complexity and Problem Solving:
Solve routine problems of limited scope and complexity following established
policies and procedures. Works on problems of limited scope. Follows standard
practices and procedures in analyzing situations of data from which answers can be
readily obtained. Builds stable working relationships internally.

Contacts are primarily with immediate supervisors, and other personnel in the
section or group
Other Job Requirements
100% On-site
Limited to no travel expected.
The following physical abilities are required to fulfill the job duties:
Repetitive bendings and reaching to setup and break down equipment
Ability to work around chemicals
Abiltiy to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases Ability to walk and stand for periods of time