SUMMARY: Oversees daily chemistry lab operations, including formulation, mixing, material handling, and inventory control. Develops and reviews procedures, batch records, and protocols to ensure accurate documentation and compliance with regulatory standards. Troubleshoots chemical-related production issues and coordinates microbiological testing and environmental monitoring. Acts as the primary liaison for vendors and supports procurement activities. Ensures staff are properly trained and contributes to Quality Management System processes such as audits, deviations, and corrective actions. Maintains compliance with ISO and regulatory requirements while driving continuous improvement and cost-efficiency initiatives.
DUTIES AND RESPONSIBILITIES
- Oversees and/or performs all chemistry lab operations, including formulation, mixing, material handling, and incoming/receiving verification.
- Prepares and/or reviews test chemistry related procedures, standard operating procedures, batch records, and protocols as assigned.
- Generates and/or reviews chemistry batch records, ensuring that data and results are recorded as specified in documented procedures.
- Monitors chemical inventory in-process on the production floor and within the laboratory.
- Performs troubleshooting and investigation of issues related to chemical points on the production floor.
- Coordinate periodic microbiological testing, including bioburden, dose audits, and environmental monitoring.
- Serves as the primary point of contact for chemistry related vendors and support procurement-related activities.
- Ensures that all personnel performing chemistry related functions are adequately trained on relevant procedures.
- Supports Quality Management System functions, including internal/external audits, deviations, non-conformances, corrective/preventative action, document/record review, and other duties as assigned.
- Complies with all in-house and regulatory requirements, including ISO 13485, 21 CFR Part 820, EU and UK MDR.
- Fosters a culture of continuous improvement by seeking cost-saving opportunities and process improvements and perform any other duties as assigned by management.
QUALIFICATIONS
- Bachelor’s Degree (BA) from four-year college or university, or five years of experience and/or training in a GMP regulated environment.
- Prior experience working in a laboratory environment, preferred.
- Familiarity with basic computer skills and the ability to work with Microsoft Office and other related software.
- Excellent analytical, oral, and written communication skills.
- Other Skills Required:
- Familiarity with GMPs and regulatory requirements.
- Commitment to excellence and high standards.
- Ability to perform calculations in the chemical formulation process.
- Can support various workloads and manage priorities and workflow.
COMPETENCIES
- Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Innovation--Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
- Design—Generates creative solutions; translates concepts and information into images; uses feedback to modify designs; apply design principles; Demonstrates attention to detail.
- Quality--Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- The physical demands and environmental characteristics 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 these essential functions.
- While performing the duties of this job, the employee is regularly required to sit or stand; use hands and fingers to handle or feel; reach with ands and arms; and talk or her.
- The employee must frequently lift and/or move up to 35 pounds.
- The employee must wear Personal Protective Equipment (PPE) while performing some of duties of this job.