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Senior Analyst, Quality Control (Night Shift - 12-hour rotating 2/2/3)
National Resilience
IT, Quality Assurance
west chester, oh, usa
Posted on Oct 24, 2024
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
NOTE: This is a Night Shift position and will following a 12-hour (2/2/3) rotating schedule.
Position 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
Minimum Qualifications:
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.
Preferred Qualifications:
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
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including equity, 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. Our target base pay hiring range for this position is $70,000.00 - $107,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.