Quality Control Specialist
2 weeks ago
Job Summary:
We are seeking a highly skilled Quality Control Scientist to join our team at Randstad Life Sciences US. As a Quality Control Scientist, you will be responsible for performing testing of raw materials, in-process samples, finished products, stability samples, and cleaning samples in support of release of materials.
Key Responsibilities:
- Conduct daily activities in accordance with clients' rules and regulations.
- Perform testing of raw materials, in-process samples, finished products, stability samples, and cleaning samples in support of release of materials.
- Provide project support through defined testing requests, compilation of data, and reporting of findings to supervisor and/or project lead.
- Perform technical and compliance review of complex analytical tests.
- Execution of testing protocols without deviation.
- Willingness to work on Safebridge Category I-III compounds.
- Perform training of other scientists on standard analytical techniques.
- Maintain analytical equipment (periodic calibration and maintenance) in accordance with PI policies and procedures.
- Maintain files as directed.
- Perform data entry into spreadsheets and proprietary computer systems.
- Operate following clients' policies and procedures to meet cGMP regulations and ICH guidelines.
- Maintain documentation in an accurate, clear, and concise manner in accordance with company policies and procedures.
- Maintain a clean, safe, and orderly workplace, following all applicable EHS policies and procedures.
Requirements:
- BS degree in chemistry or biology or related field.
- 2+ years of experience in a GMP analytical laboratory.
- Accurate documentation and observation skills.
- Working knowledge of the cGMP regulations preferred.
- Working knowledge of safe handling practices of dangerous chemicals.
- Computer skills (spreadsheet, database, and word processing window-based programs).
- Hands-on experience with the operation and maintenance of analytical instrumentation preferred (Polarimetry, pH and conductivity meters, Automatic titrators, TOC, HPLC or GC using Empower).
- Excellent communication skills.
Physical Requirements:
- Must have good hearing and sight – adequate for safety programs in a pharmaceutical manufacturing plant.
- Must be able to sit and/or stand for extended periods.
- Ability to work effectively under pressure to meet deadlines.
- Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening.
- Must be able to lift 25 lbs. or occasionally lift up to 35 lbs.
- Ability to wear proper safety equipment when working in the laboratory or plant.
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