Senior Analyst, Quality Control (Weekend Shift)

Resilience • West Chester, OH

3d • $75,000 - $116,250

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 Position Description This 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. Conducts 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.

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

• 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 other QC employees(peers) 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 role may require collaboration and communication within the team and with operations groups/QA

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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

What This Job Offers

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