Quality Control Analyst II Microbiology, Analytical Science & Technology

Alcon•Fort Worth, TX

7d•Onsite

About The Position

The Quality Control Analyst II Microbiology, Analytical Science & Technology is primarily responsible for maintaining high standards of laboratory operations and ensuring compliance with regulatory requirements. This role performs microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET. It provides support to QC Microbiology laboratories, conducts equipment qualifications, and supports audits. The role also involves organizing and assisting with Media Fill and Reads, identifying ongoing quality issues, preventing potential problems, and suggesting improvements. The analyst interprets and evaluates analyses for accuracy and precision against established specifications, recommending and implementing corrective actions when necessary. Responsibilities may include analytical and protocol report writing, as well as standard operating procedures, while strictly adhering to Good Documentation Practices (GDP). The role requires collaboration with and support of coworkers to enhance the organization's overall capabilities, effective communication with production, maintenance, warehouse, and other relevant functions, and participation in problem-solving and troubleshooting. Additionally, the analyst supports the training needs of team members, works cohesively with the team, and coordinates with other departments to ensure smooth workflow execution. Ensuring the availability of supplies and equipment to meet schedules and carry out tasks as defined by the schedule is also a key function.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
The ability to fluently read, write, understand and communicate in English

Nice To Haves

Flexibility to work Overtime hours, if needed.
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

Responsibilities

Performs microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET.
Provides support to QC Microbiology laboratories.
Conducts equipment qualifications.
Supports audits.
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 carry out tasks as defined by the schedule.