Quality Control Laboratory Manager

2 weeks ago


Dallas, Texas, United States Aloe Vera of America, Inc. Full time
Job Overview

POSITION SUMMARY: The Quality Control Laboratory Manager oversees all operations and personnel within the Quality Control Laboratory, specifically focusing on the Chemistry Lab.

KEY RESPONSIBILITIES:
To ensure effective performance, reasonable accommodations may be made for individuals with disabilities to fulfill essential functions.

• Manage daily laboratory activities, including task assignments, scheduling, and training of laboratory analysts.

• Support the implementation of quality standards and regulatory compliance.

• Initiate and oversee change control processes related to laboratory testing requirements.

• Lead investigations into Out of Specification (OOS) results and implement corrective measures.

• Organize analytical validation protocols.

• Review and authorize analytical data.

• Release finished products and raw materials from the Quality Control Laboratory.

• Prepare the laboratory for regulatory inspections and internal audits, ensuring readiness.

• Assess and suggest enhancements to analytical methodologies.

• Troubleshoot instruments and methods within established analytical parameters.

• Ensure compliance with current Good Manufacturing Practices (cGMPs) by reviewing testing records and logbooks.

• Document and develop strategies to monitor and evaluate the achievement of scientific objectives.

• Act as a subject matter expert within the analytical laboratory, providing necessary support.

• Assist in the creation of Standard Operating Procedures (SOPs), policies, and guidelines for the department.

• Adhere to company SOPs and policies.

• Perform duties of QC Lab Technicians and Chemists as required.

• Conduct annual reviews of data generated by the Quality Control Laboratory, analyzing trends and presenting findings to the Quality Control Laboratory Manager.

SUPERVISORY DUTIES:

• This role supervises departmental employees and collaborates with the Quality Control Lab Manager on performance management and recruitment.

• Implement performance management processes, including planning, monitoring, and evaluating employee performance.

• Provide training, constructive feedback, and conduct performance evaluations for direct reports.

• Enforce adherence to company policies.

QUALIFICATIONS & SKILLS:

• Comprehensive understanding of chemistry testing protocols and the capability to enhance laboratory procedures.

• Profound knowledge of ISO 17025 and 21 CFR Good Manufacturing Practices.

• Strong communication skills, both verbal and written, with the ability to provide clear instructions to laboratory personnel.

• Excellent observational skills.

• Proficient in Microsoft Office applications.

• Exceptional attention to detail and accuracy.

• Strong analytical and problem-solving abilities.

PHYSICAL REQUIREMENTS:

• Manual dexterity to operate testing equipment and conduct tests.

• Ability to lift up to 20 lbs. as necessary.

• Capacity to sit for up to one hour at a time.

• Ability to stand for extended periods, up to four hours.

• Capability to bend, squat, kneel, and reach overhead.

• Good hand-eye coordination and visual acuity for setting up equipment and performing tests.

EDUCATION & EXPERIENCE:

• Bachelor’s degree in chemistry or a related scientific field.

• Minimum of 2 years of supervisory experience in a laboratory setting, particularly in pharmaceutical or dietary supplement manufacturing.

Aloe Vera of America, Inc. is committed to providing equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind based on race, color, religion, age, sex, national origin, disability, genetic information, or any other characteristic protected by federal, state, or local laws.



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