Lead Technician- QA PAR (Day Shift)

Role Summary

Lead Technician- QA PAR responsible for providing QA oversight to GMP operations, supporting start-up and qualification activities at the Concord site, and collaborating cross-functionally with various levels of the organization. The role will transition to supporting and escalating issues from manufacturing to the site-based process team for Formulation and Equipment Preparation, Parenteral Filling (Pre-Filled Syringes), or Automated and Semi-automated Visual Inspection as the project progresses.

Responsibilities

• Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area.
• Follow good documentation practices and compliance with site procedures.
• Review and approve GMP documentation such as electronic batch records, logbooks, etc.
• Support creation of Standard Operating Procedures and associated Forms, Tools and Training.
• Troubleshoot and provide support to resolve equipment alarms and other issues in quality systems such as Veeva and MES.
• Maintain open communications between cross functional teams and area leadership.
• Support the execution of inspection readiness activities including support of site self-inspections.
• Support project initiatives needed for the project and Quality function.
• Communicate any compliance issues associated with the project or site to Quality Management.
• Evaluate potential product quality impact for any GMP-related incident and support the investigation and assist with safety investigations.

Qualifications

• Required: High School diploma or equivalent
• Required: Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Required: Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills
• Required: Strong attention to detail
• Required: Ability to work independently with minimal supervision
• Required: Proficiency with computer systems including Veeva, MES, Microsoft Programs
• Required: Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
• Required: Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B paths or at R1 Level.

• Preferred: Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study
• Preferred: Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection
• Preferred: Previous experience with Manufacturing Execution Systems (MES) or electronic batch records
• Preferred: Previous technical writing experience
• Preferred: Technical aptitude and ability to train and mentor other team members

Additional Requirements

• Ability to work 12 hour shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work)
• Overtime and off-shift support may be required
• May be required to respond to operational issues outside of core business hours and days
• May be subject to post-offer physical and vision exam
• Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting
• Must have ability to lift 30lbs