GxP Validation

TalentOla•Fort Worth, TX

19h•Onsite

About The Position

The Quality Control Analyst II is responsible for maintaining high standards of laboratory operations and ensuring compliance with regulatory requirements. Key responsibilities include performing microbiological validations for raw materials and finished products, providing support to QC Microbiology laboratories, conducting equipment qualifications, and organizing and assisting with Media Fill and Reads. The role involves identifying ongoing quality issues, preventing potential problems, and suggesting improvements. The analyst will interpret and evaluate analyses for accuracy and precision, recommend and implement corrective actions, and may be responsible for analytical and protocol report writing, as well as standard operating procedures. Strict adherence to Good Documentation Practices (GDP) is required. The position involves collaboration with and support of coworkers, effective communication with production, maintenance, warehouse, and other relevant functions, and participation in problem-solving and troubleshooting. The role also includes supporting training needs of team members, working cohesively with the team, and coordinating with other departments to ensure smooth workflow execution. Ensuring the availability of supplies and equipment to meet schedules and carrying out tasks as defined by the schedule are also key aspects of the role.

Requirements

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

Nice To Haves

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.
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.