Quality Control Analyst II
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, including Bioburden, Endotoxin, Sterility, and PET. This role provides support to QC Microbiology laboratories, conducts equipment qualifications, and organizes and assists with Media Fill and Reads. The analyst identifies ongoing quality issues, prevents potential problems, and suggests improvements. They interpret and evaluate 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. The role requires strict adherence to Good Documentation Practices (GDP). Collaboration with and support of coworkers is essential to enhance the organization's overall capabilities. Effective communication with production, maintenance, warehouse, and other relevant functions is expected. The analyst participates in problem-solving and troubleshooting, supports the training needs of team members, and works cohesively with the team. Coordination with and support of other departments ensures 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 duties.
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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
