Analyst II, Quality Control

Resilience • West Chester, OH

2d • $60,000 - $86,250

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Job Summary The Analyst II, Quality Control performs routine and non-routine testing of raw materials, components (including packaging), finished products, stability, water, and environmental samples in compliance with established methods and regulatory requirements. The role also conducts GMP reviews of laboratory documentation and electronic data, communicates findings to analysts, and supports data integrity and continuous improvement within the Quality Control laboratory. This a Night Shift position working 6pm - 6:30am. 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts over again.

Requirements

• Analytical experience in a GMP facility using various types of instrumentation (HPLC/GC) 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

• Performs testing on a range of samples, including chemical raw materials, components(including packaging materials), finished products, stability samples, water, and environmental samples.
• 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.
• This position may require operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting
• 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

Benefits

• Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees