ELID - Quality Specialist

Job Summary

The Quality Specialist focuses on providing administrative support to the Quality and Regulatory department. This includes but is not limited to:

• Review of various GMP documents including but not limited to batch records, cleaning records, and raw material records.
• Maintenance and filing of controlled documents.
• Filing of GMP and SOP acknowledgement and training documents.
• Generation of various GMP reports
• Maintaining of training database and making sure all training has been completed when new SOPs have been routed
• Scanning and filing of current and retained GMP documents.
• Providing other support functions as required to the QA, QC and Regulatory department.
• Maintenance of existing and creation of new raw material files.
• Assistance in complying with customer requirements.

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.

Ideal Candidate

Qualifications:

• Knowledge of GMP requirements pertaining to the personal care and OTC drug industry is required.
• Experience with document control specifically related to manufacturing quality documents, specifications and SOPs preferred.
• Must be able to work independently and effectively with a high level of accuracy.
• Must have a very high attention to detail and good organization skills.
• Must be able to communicate effectively in writing and verbally in the English language.
• Must have knowledge of how to operate and use a computer.
• Must be able to perform mathematical calculations and verify the accuracy of calculations by others.
• Must be able to perform basic research functions and manipulate information effectively.
• Good communication skills are required.
• Must be able to communicate deviations and other information effectively and professionally with peers necessary for compliance.
• Perform essential duties and responsibilities efficiently, accurately, and safely.

• ERP
• Microsoft Excel
• Microsoft Word
• Internet applications

• 1+ year experience in manufacturing environment preferred
• HS Diploma or equivalent
• 1-2 years Quality Control experience preferred.

• 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.

• Office setting
• Noise level is usually moderate
• Fast paced