Quality Assurance Manager

JOB SUMMARY:

Managing Quality Assurance focusing on auditing functions of the quality unit and microbiological, controlled environment, ISO, cGMP, FDA compliance, and other certifications.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Review and revision of various GMP and ISO documents
2. Oversee the Quality Assurance team.
3. Maintain Quality Manual and SOP's.
4. Perform APR's (Annual Product Reviews) for OTC and medical devices.
5. Support Environmental testing and monitoring program of the facilities and controlled environment.
6. Oversee and support Customer Complaints, CAPA, Root Cause Analysis, and Change Control activities.
7. Support activities within the organization to improving quality.
8. Support engineering and validation activities. Responsible for process validation protocol writing and final report generation.
9. Prepare and review reports related to environmental monitoring, engineering and validation activities.
10. Host and support Customer and Regulatory audits.
11. Perform qualification activities as needed and review of environmental controls (controlled environment, hoods, temperature and humidity).
12. GMP annual training and orientation training.

SECONDARY DUTIES AND RESPONSIBILITIES:

1. Perform other duties as assigned or needed.

Elevation Labs provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Elevation Labs complies with applicable state and local laws governing nondiscrimination in employment at every location in which the Company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

The essential duties listed are representative of the major duties required of this job; ability to perform the essential functions with or without reasonable accommodation is required. Elevation Labs may make reasonable accommodation to the known physical or mental limitation of otherwise-qualified individuals with disabilities unless the accommodation would impose an undue hardship on the operation of our business.

This job description is not designed or intended to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required for this job. Specific duties and responsibilities may vary based upon departmental needs. Incumbent may be asked to perform other duties as assigned.

KNOWLEDGE & SKILLS:

Ideal Candidate Qualifications:

• Knowledge of GMP requirements pertaining to the personal care, OTC, and/or Medical Device industry.
• High attention to detail
• Must be able to communicate effectively in writing and verbally in the English language.
• Good communication skills are required. Must be able to effectively and professionally communicate deviations and other information with peers necessary for compliance.
• Must be able to perform mathematical calculations and verify the accuracy of calculations by others.
• Knowledge of lean manufacturing principles and other continuous improvement tools.
• Must be able to perform basic research functions and manipulate information effectively.
• Must have knowledge of how to operate and use a computer.
  • ERP
  • Microsoft Excel
  • Microsoft Word
  • Internet applications

EDUCATION/EXPERIENCE:

• BS Degree or related field or on the job experience in quality in manufacturing environment or related field.

PHYSICAL/MENTAL DEMANDS:

• Regularly/Frequently required to sit, stand, walk, stoop, kneel, bend.
• Regularly/Frequently use hands to keyboard or type, handle materials, or manipulate tools.
• Regularly reach with hands and arms.
• Occasionally/Frequently lift and/or move up to 25 pounds and, infrequently, up to 50 pounds.
• Specific vision abilities required by this classification include close vision, depth perception and ability to adjust focus.
• Sufficient clarity of speech and hearing abilities required by this classification includes those which permit the employee to discern verbal instructions and communicate effectively in person and by telephone.
• Requires composure and ability to prioritize and handle many urgent tasks and requests simultaneously with a high level of competence and accuracy.
• Maintain confidentiality.

The physical demands identified above are representative of those that will be required to successfully perform the essential functions of this job.

WORK ENVIRONMENT:

• Office setting
• Noise level is usually moderate
• Fast paced
• Production and warehouse environment
• Physical testing and microbiological laboratory