QC Analyst II (Stability) *PC 1493

Your Role:

This position is primarily responsible for executing and coordinating day-to-day activities under close supervision to support the stability programs (lentiviral vector, plasmid, buffer/media, cell banks) in compliance with internal company policies and regulatory guidance (ICH, CFR, etc.).

Essential Duties and Responsibilities: 

• Author stability-related documentation (e.g., protocols, testing certificates of analysis, trending summaries, standard operating procedures).
• Ensure timely completion of scheduled stability sample pulls per the relevant protocols and stability program SOPs; assist in the maintenance of the stability pull calendar.
• Perform review of analytical data and enter stability results into QC databases; perform data trending.
• Maintain stability chamber organization; independently perform routine inventory of all stability samples including retain and reference samples.
• Initiate contract laboratory purchase orders for stability and release testing; coordinate sample shipments to contract laboratories and/or sample storage vendors.
• Identify out of trend or atypical results and supports ongoing investigations, Initiate quality event investigations for deviations, OOT, OOS, and CAPA events.
• Interact with functional peer groups; provide stability data to other departments upon request.
• Support and assist with documenting stability program metrics in support of management review.

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; 2-4 years of experience working in a cGMP laboratory and performing hands on work in a Quality Assurance/Quality Control setting; Or a combination of education and experience. 
• The ideal candidate will have a basic knowledge of analytical methods used for protein chemistry, molecular biology, and microbiological testing.
• General knowledge of regulatory guidelines (i.e., ICH, FDA, EU) related to stability is desirable.
• Experience with inventory management and trending data is desirable.
• Experience trending data and use of JMP statistical software is preferred.
• 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 anticipated base salary range has been established at $34.71 - $46.97/per hour. The hiring range for this position is expected to fall between $34.71-$37.77/per 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. 

The salary of the finalist(