Quality Control Analyst

Company : LanceSoft Inc

• 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

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