Lead Technician QA PAR (Night Shift)

Role Summary

The Lead Technician QA provides QA oversight to GMP operations and supports start-up and qualification activities for the Concord site. The role collaborates cross-functionally and will escalate manufacturing issues to the site-based process team, with responsibilities spanning formulation and equipment preparation, parenteral filling, and automated visual inspection.

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 Trackwise 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 Trackwise, MES, Microsoft Programs
• Required: Responsible for maintaining a safe work environment, working safely and supporting all HSE corporate, project, and site goals
• Required: Legally authorized to work in the United States (no visa sponsorship anticipated for this role)
• 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

Education

• Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study (preferred)

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
• May be subject to post-offer physical and vision exam
• Job involves repetitive movements and requires the ability to lift up to 30 lbs