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Quality Control Analyst II Microbiology

Aequor

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


Custom Fields:
Name: Supervisory Org
Value: Analytical Science and Technology (AS&T) - Micro/ARS(Harshini Soma)-60004322


Name: Work Desk Phone Number Required
Value: No


Name: Worker Time Type
Value: Full Time


Name: Remote Worker
Value: No


Name: Badge ID Required
Value: Yes


Name: System Access Required
Value: Yes


Name: Workspace
Value: None


Name: Invoice Type
Value: USA-ARL-Staffing-USD
Vacancy posted 3 days ago

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