QC Analyst

Job Title: QC Analyst
Location: Clayton, NC
Duration: 12 months+
Shift time: Standard
 
Description:
Skills:

• Preparation of Microbiological media
• Washing and sterilization with autoclaves of equipment and media
• Reading and interpretation of Environmental monitoring samples
• Bioburden testing of utilities samples via membrane filtration

 
Purpose:
Perform & review analysis of in-process, release & stability samples of API &/or filled product in accordance with cGMP, site & corporate procedures & policies. Transfer of technology & processes in accordance with relevant project plans & timelines.
 
Essential functions:

• Ensure accuracy & scientific soundness of lab data
• Ensure environmental compliance
• Support & ensure GMP Laboratory Compliance
• Maintain testing proficiency for methods
• Ensure timeliness of lab results & investigations
• Perform analysis of samples. Support deviations
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned.

Physical requirements:

• Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
• Ability to do close precision work with their hands.
• Must be able to remain in a stationary position (sitting and standing) 50% of the time.
• Occasionally ascends/descends a ladder.
• May be required to work at elevated heights.
• Occasionally works around odorous &/or hazardous materials.
• Vision screening NOT REQUIRED.
• Color Vision NOT REQUIRED.

Qualifications:

• Associate's degree in science or a relevant field of study from an accredited university required
• Bachelor's Degree in science or a relevant field of study from an accredited university preferred One (1) year of work experience in a clinical or industrial/pharmaceutical laboratory preferred
• Ability to author scientific & technical reports is a plus
• Able to perform routine testing per SOP & GMP standards preferred
• Basic level of troubleshooting for laboratory equipment is a plus
• Knowledgeable in GMP & laboratory techniques is a plus
• Demonstrate attention to detail required
• Strong communication skills (verbal & written) preferred
• Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, PH, KF), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA, BIOBURDEN) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UVVis) is a plus.

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