Quality Lab Associate
1 week ago
Job Summary
The Quality Lab Associate I will be responsible for conducting analytical testing, validation/verification, and/or transfer of test methods supporting parenteral products. This role is essential for supporting the global commercial product teams and/or product development teams.
Key Responsibilities
- Conduct critical chemical, physical, and biological analyses on finished product stability samples.
- Support testing of raw materials, initial, in-process and final product samples from the manufacturing facility, as required.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations.
- Participate with management to investigate deviations and write exception documents.
- Perform advanced biological and chemical assays requiring precise analytical skills and understanding of chemistry principles.
- Perform review of test data, which includes overall documentation practices.
- Participate in cross functional teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality and provide new product support.
Requirements
- Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis.
- Must demonstrate effectiveness in attention to detail, organization, teamwork/interpersonal skills, results orientation, and task completion.
- Must be able to handle multiple tasks concurrently and in a timely fashion.
- Possess writing and computer skills.
- Must communicate effectively with managers and peers.
- Interpret available information and make recommendations to resolve technical challenges.
Education and/or Experience
Bachelor's degree in Chemistry or biological science with analytical chemistry laboratory coursework and 0-1 years' experience. Analytical chemistry instrumentation experience (e.g. HPLC, pH, KF, AA, GFAA, titrations, etc.) preferred. Pharmaceutical GMP/QC laboratory experience is desired.
About DivIHN
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
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