Quality Control Analyst II Microbiology

Key responsibilities include: -Performs microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET. -Ensures the availability of supplies and equipment to meet schedules and carries out tasks as defined by the schedule.

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