Senior Analyst, Quality Control (Night Shift)

Resilience•West Chester, OH

1d•$75,000 - $116,250•Onsite

About The Position

The Senior Analyst, Quality Control performs testing on a range of samples, including chemical raw materials, components (including packaging materials), finished products, stability samples, water, and environmental samples. This role may require collaboration and communication within the team and with operations groups/QA. The role may require individuals to autonomously perform tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site, including data review and on-the-floor sampling. This position may require operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.

Requirements

Analytical experience in a GMP facility using various types of instrumentation (HPLC) required, including proficiency with chromatography software (i.e. Empower, etc.)
Proficient in math, laboratory and computer skills.
Understand basic statistics and quality control terminology.
Working knowledge of laboratory equipment (including HPLC), operations, and safety.
Good problem-solving skills.

Nice To Haves

Bachelor’s degree in Chemistry, biology or related field
QC chemistry laboratory experience in the pharmaceutical industry
Working knowledge of cGXP requirements and a strong familiarity with production operations

Responsibilities

Conduct GMP review of laboratory documentation including review of electronic data in a timely manner for compliance with applicable SOPs, test methods, regulations, and protocols.
Communicate findings to analysts and follow up on corrections.
Assist in authoring and finalizing departmental SOPs.
Evaluates data trends and actively participates in the investigation of OOS and atypical events and/or quality issues placing particular attention to root cause analysis, technical completion and scope while ensuring accuracy of documentation contents.
Provides and follows up on ideas for continuous improvements in laboratory processes.
Maintains and troubleshoots testing equipment.
Participates in investigations for PET process areas related to QC processes or data.
Trains QC employees in good analytical techniques, methods and instrumentation based on expertise.
Actively support the implementation of compendial changes for raw materials, chemical methods or finished products tests in accordance with applicable Pharmacopoeias such as USP/NF, European Pharmacopeia, British, and Japanese Pharmacopeia.
Troubleshoots methods and processes.
Leads continuous improvements in laboratory processes.
Trains QC employees in GMP, SHE, QC methods and processes.
May serve as an expert in a specific area of laboratory equipment, process, or system and supports regulatory audits.