Senior Quality Control Analyst I (Micro) *PC 1494

Your Role:

This position is primarily responsible for executing day-to-day activities under minimal supervision to support the microbiology programs (lentiviral vector and cell and gene therapy) in all stages of development in compliance with internal company policies and regulatory guidance (ICH, CFR, etc.). To be considered for this position, candidates must meet the minimum education, experience and skills listed in the applicable section.

Essential Duties and Responsibilities: 

• Receive and track sample submissions from multiple departments.
• Perform microbiological testing activities (e.g. bioburden, endotoxin, sterility, special studies, method qualifications).
• Conduct and write investigations independently or with minimal assistance.
• Display sound scientific/technical judgment and ability to review work for overall adequacy and accuracy.
• Contribute actively to work on and resolve various scientific/technical problems of moderate scope and complexity.
• Work with minimal supervision. Follow established written procedures and processes.
• Support improving existing procedures and/or establishing new procedures.
• Identify out of trend or atypical results and supports ongoing investigations; Initiate quality event investigations for deviations, OOT, and OOS events.
• Interact with functional peer groups; provide microbiological data to other departments upon request.
• Support and assist with documenting microbiological program metrics in support of management review.
• Maintain trackers for microbial data.
• Initiate contract laboratory purchase orders for microbial testing; coordinate sample shipments to contract laboratories and/or sample storage vendors.
• Coordinate Lab equipment maintenance.

Requirements: 

• Bachelor’s (B.S.) or Master’s (M.S.) degree in biotechnology, biology, chemistry or similar field from a four-year college or university; At least 5 years prior experience in a cGMP microbiology laboratory in Quality control, and experience working with microorganism cultures.
• Strong knowledge of aseptic technique and product sample handling.
• Strong organizational skills and attention to detail are required.
• Excellent written and oral communication skills and must be able to interact with a cross-functional team member.
• Strong skills with Microsoft Office applications (Excel, Office, PowerPoint, Outlook, etc.).

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $42.99/hour - $50.57/hour, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.  

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.