Description: The Quality Control Analyst II is responsible for maintaining high standards of laboratory operations and ensuring compliance with regulatory requirements. Key responsibilities include:
-Performs microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET.
-Provides support to QC Microbiology laboratories.
-Conducts equipment qualifications.
-Organizes and assists with Media Fill and Reads.
-Identifies ongoing quality issues, prevents potential problems, and suggests improvements.
-Interprets and evaluates analyses for accuracy and precision against established specifications, recommending and implementing corrective actions when necessary.
-May be responsible for analytical and protocol report writing, as well as standard operating procedures.
-Strictly adheres to Good Documentation Practices (GDP).
-Collaborates with and supports coworkers to enhance the organization's overall capabilities.
-Communicates effectively with production, maintenance, warehouse, and other relevant functions.
-Participates in problem-solving and troubleshooting.
-Supports training needs of team members and works cohesively with the team.
-Coordinates with and supports other departments to ensure smooth workflow execution.
-Ensures the availability of supplies and equipment to meet schedules and carries out tasks as defined by the schedule.
Qualifications:
-Bachelor s Degree or equivalent years of related experience (or high school + 8 yrs; Assoc. + 4 yrs)
-The ability to fluently read, write, understand and communicate English
Desired Competencies:
-Strong knowledge of pharmaceutical regulatory requirements
-Excellent Communication skills, in both verbal and written form
-Highly attentive to details and comfortable speaking up
-Self-Starter with the ability to follow up on and complete multiple projects simultaneously with little direction
-Able to work overtime and flexible work hours to meet department goals