QA Lead- Supervisor

QA Lead-Supervisor

(Quality, Exempt) – Rochester, NY

About the position: The GreenLight team is looking for a self-motivated individual who works well in a fast-paced environment to play a pivotal role building a GMP compliant manufacturing facility to advance is product into the veterinary medicine marketplace. Reporting directly to the QA Manager, the individual will be a key contributing member of the manufacturing organization.

The candidate will assist with creation of QMS systems and governing SOPs as well as the review of executed documents (i.e., batch records, validation protocols, etc.).  Additional responsibilities will relate to activities supporting contract manufacturing quality oversite. The ideal candidate will have experience with document control and quality systems in a regulated industry setting (e.g., FDA 21 CFR Part 210/211, GLP, Veterinary Medicine). 

Key Position Responsibilities

• Create and implement standard operating procedures, protocols, reports etc.
• Review and approve quality system and batch related documentation (e.g., cGMP procedures, batch records, QC testing, Certificates of Analysis, protocols, validation reports, stability studies, etc.)
• Ability to initiate and support the management of CAPAs, deviations and investigations as well as monitor completion of such quality compliance activities.

• Provide Quality Assurance support to many cross functional teams including Manufacturing, Warehousing, Distribution, Contract Manufacturing and Quality Control departments.
• Provide mentoring and training to staff that are new to regulatory requirements and to facilitate their use of established quality systems.
• Collaborates with internal and external stakeholders to ensure that regulatory agency quality assurance requirements are met.
• Oversight of equipment status from calibration, maintenance, validation, change control, and product changeover, etc.
• Participate in Regulatory inspections and other audits, as required.
• Identify potential compliance issues and opportunities for improvement to the overall Quality System. Provide resolution of both technical and compliance issues or gaps.
• Implement process improvements to enhance compliance and improve methods and product quality processes
• Perform duties regarding special projects, as assigned by Quality Management.

Position Requirements

• Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management.
• Non-degreed candidates with 10+ years combined of relevant GLP/GMP quality systems experience will be considered.

• Thorough knowledge of applicable GLP / GMP regulations, ICH & FDA guidelines, and other applicable regulatory guidance (US and EU).

• Familiarity with global cGMP and ISO regulations relating to veterinary medicinal products is a plus

• Understanding of Quality concepts/requirements and be able to practice and implement them, as well as GMP Manufacturing processes.

• Experience creating /reviewing / approving documentation such as Standard Operating Procedures (SOPs), Work instructions, Batch Records, protocols, etc.
• Experience with performing audits and participating in audits to include regulatory agency inspections.
• Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a collaborative and engaged environment.

• Self-motivated, strong work ethic, organizational skills, communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.

• Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges.

• Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).