Clinical and Scientific - Quality Control Analyst II

Mindlance

Fort Worth, TX

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JOB DETAILS

SKILLS

Analysis Skills, Biotech and Pharmaceutical, Communication Skills, Corrective Action, Documentation, English Language, Follow Through, Identify Issues, Laboratory, Laboratory Operations, Maintain Compliance, Microbiology, Multitasking, Problem Solving Skills, Quality Control, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Schedule Development, Secondary School, Standard Operating Procedures (SOP), Time Management, Warehousing

LOCATION

Fort Worth, TX

POSTED

17 days ago

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

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

Clinical and Scientific - Quality Control Analyst II

Mindlance

Fort Worth, TX

About the Company

Mindlance

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