BioSpace
Job Summary
The Analyst, QC Aseptic Control is responsible for reviewing sampling and laboratory data and autonomously performing tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified/non‑classified areas up to a Grade A aseptic environment and in a laboratory setting, and includes the maintaining of gowning qualification. This is a Monday‑Friday day shift position. Position Responsibilities
Supports coordination of workflow for Environmental Monitoring team. Verifies QC data, while monitoring for trends and abnormalities. Trained and able 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 compliance. Troubleshoots methods and processes. 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 Analyst II/Team Lead when absent. 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. Other duties that support Environmental Monitoring, Operations, or Laboratory processes may be assigned. Minimum Qualifications
General experience in a pharmaceutical production or quality control environment (GMP/GDP). Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language. Good attention to detail is required. Must be capable of keeping accurate records and performing mathematical calculations. Preferred Qualifications
Bachelor’s degree in a scientific discipline. Significant experience in a sterile or cGXP environment. Lab experience. Other Information
Sponsorship or support for work authorization, including visas, is not available for this position. Equal Employment Opportunity Statement
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. Benefits and Compensation
Benefits include an annual cash bonus program, a 401(k) plan with a generous company match, health care (medical, dental, vision), family building benefits, life and disability insurance, flexible time off, paid holidays, paid leaves of absence, tuition reimbursement and support for caregiving needs. The target base pay hiring range for this position is $24.00 – $34.50 per hour.
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The Analyst, QC Aseptic Control is responsible for reviewing sampling and laboratory data and autonomously performing tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified/non‑classified areas up to a Grade A aseptic environment and in a laboratory setting, and includes the maintaining of gowning qualification. This is a Monday‑Friday day shift position. Position Responsibilities
Supports coordination of workflow for Environmental Monitoring team. Verifies QC data, while monitoring for trends and abnormalities. Trained and able 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 compliance. Troubleshoots methods and processes. 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 Analyst II/Team Lead when absent. 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. Other duties that support Environmental Monitoring, Operations, or Laboratory processes may be assigned. Minimum Qualifications
General experience in a pharmaceutical production or quality control environment (GMP/GDP). Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language. Good attention to detail is required. Must be capable of keeping accurate records and performing mathematical calculations. Preferred Qualifications
Bachelor’s degree in a scientific discipline. Significant experience in a sterile or cGXP environment. Lab experience. Other Information
Sponsorship or support for work authorization, including visas, is not available for this position. Equal Employment Opportunity Statement
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. Benefits and Compensation
Benefits include an annual cash bonus program, a 401(k) plan with a generous company match, health care (medical, dental, vision), family building benefits, life and disability insurance, flexible time off, paid holidays, paid leaves of absence, tuition reimbursement and support for caregiving needs. The target base pay hiring range for this position is $24.00 – $34.50 per hour.
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