Quality Control Lab Analyst

As a key member of our growing team, the Quality Control Laboratory Analyst/Analytical Chemistry Technician will support a wide range of Quality Control and Quality Assurance activities. In addition to routine sampling and analytical testing, this position will assist in developing and improving laboratory procedures, supporting regulatory compliance and helping to maintain a robust Quality System.

This is an onsite role in Rochester, New York.

Specific Duties and Responsibilities:
* Perform chemical and wet chemistry testing on raw materials, in-process samples and finished products.
* Support the development and continuous improvement of procedures, SOPs and forms.
* Assist in implementing and maintaining Quality Management System (QMS) components for a GMP-compliant environment.
* Sample and inspect incoming raw materials and components.
* Maintain clear and accurate documentation in laboratory notebooks or electronic systems, following Good Documentation Practices (GDP).
* Troubleshoot equipment and support preventative maintenance and calibration activities.
* Participate in quality investigations, change controls, CAPAs, NCRs, audits and facility inspections.
* Help manage and organize the laboratory space, supplies, waste and safety systems.
* Assist in preparation of reports, data summaries and internal presentations.
* Work closely with manufacturing, facilities, engineering and product development to promote a culture of quality across all functions.

Qualifications (Education, Experiences and Skills):
* Quality Control Laboratory Analyst/Technician -Bachelor's Degree in Chemistry, Engineering, or related technical field with 0-5 years of experience in a FDA/GMP regulated laboratory.
* Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
* Understanding of cleanroom behavior and gowning procedures in controlled environments
* Ability to work independently and collaboratively
* Strong documentation, organizational and communication skills
* Preferred: familiarity with laboratory equipment such as pH meter, balances, Osmolality and Conductivity meters. Experience with SAP/LIMS (Laboratory Information Management Systems).

Physical Requirements:
* Fifty (50) pound lifting, carry, push, pull, or otherwise move objects.
* Ability to climb a platform/ladder.
* Ability to stand/walk for long periods of time.