Job Summary

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.

Position 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.
• 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

Hours (Night Shift):

• 6pm - 6:30am
• 2/2/3 Schedule (12-Hour Rotating)

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.

The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

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. Our target base pay hiring range for this position is $75,000.00 - $116,250.00 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? We encourage you to apply and start a conversation with one of our recruiters.