Analyst II, QC Aseptic Control, Lead (Night Shift - 12-Hour Rotating, 2/2/3 Schedule)

Initial Therapeutics, Inc.; Olde West Chester (OH); On-site; USD 60,000 - 83,000; Full time

Job summary

An established industry player is seeking a dedicated Environmental Monitoring Technician to support regulatory compliance in a sterile manufacturing environment. This role involves operating equipment, scheduling work, and leading investigations to ensure quality control and adherence to Good Manufacturing Practices. You will play a crucial part in a groundbreaking biomanufacturing company that is revolutionizing the production of medicine. If you are detail-oriented and passionate about quality assurance, this opportunity is perfect for you!

Benefits

401(k) plan with company match

Annual cash bonus program

Flexible time off

Tuition reimbursement

Comprehensive healthcare benefits

Paid holidays

Life and disability insurance

Qualifications

• Experience in pharmaceutical production or quality control in a GMP environment.
• Ability to maintain accurate records and perform calculations.

Responsibilities

• Schedule work and troubleshoot methods in Environmental Monitoring.
• Lead investigations and coordinate workflow in the team.
• Train others and ensure compliance with quality standards.

Skills

Attention to Detail

Mathematical Calculations

Communication Skills

Education

Bachelor's degree in a scientific discipline

Job description

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 Summary:
This position autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. This includes operating equipment in various classified/non-classified areas up to a Grade A aseptic environment and in a laboratory setting and maintaining gowning qualification. In addition, the incumbent will perform tasks related to scheduling work and loads, reviewing sampling and lab data, performing project work, leading laboratory investigations, and training and coaching colleagues.

Shift & Hours:

• Night Shift - 2/2/3 Rotating Schedule
• 6pm - 6:30am

Position Responsibilities:

• Schedule work and load the correct pulls in Environmental Monitoring System
• Troubleshoot methods and processes
• Develop methods and processes
• May serve as the primary link between QC team and Operations for day-to-day activities, such as schedules and workload planning
• Coordinate workflow in Environmental Monitoring team
• Verify QC data while monitoring for trends and abnormalities
• Maintain training to perform all Environmental Monitoring technician responsibilities (including maintaining aseptic qualification) when needed
• Review completed production documentation (for example: logbooks) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance
• Assign work tasks and activities to others
• Perform logbook reviews
• Train others on systems, software, equipment, machines, procedures, and/or processes
• Answer compliance and process questions from others
• Communicate policies and procedures to employees
• Fill in for immediate supervisor when needed
• Gather, organize, and communicate operational information to others
• Lead and coordinate investigations and studies with little supervision
• Lead process improvement activities and teams to meet strategic goals
• Communicate priorities and progress to team on a continuing basis
• Ensure that employees have the tools needed to perform their jobs
• Monitor training of employees to ensure compliance
• Perform other duties that support Environmental Monitoring, Operations, or Laboratory Processes

Minimum Qualifications:

• Prior experience in a pharmaceutical production or quality control role (i.e. Microbiology or Environmental Monitoring) in a GMP environment
• Capable of keeping accurate records and performing mathematical calculations
• Ability to effectively understand, read, write, communicate and follow instructions in the English language
• Thorough attention to detail

Preferred Qualifications:

• Bachelor's degree in a scientific discipline
• Prior experience in a sterile or cGxP environment

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 $60,000.00 - $82,500.00 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.