The position is responsible for performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, and corporate policies and procedures.
Independently perform audits of records and reports and inspects both raw, in-process and final product conditions (accuracy, quality and quantity) to assure compliance with applicable customer requirements, and corporate policies and procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Assure Omnimax compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor.
· Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
· Review SOPs, protocols/batch records, reports, and other quality and regulated records involving issues and processes for accuracy and compliance with all applicable regulations and internal policies.
· Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
· Participate in the preparation and review of study and QA files in preparation for sponsor site visits and regulatory inspections; assure that QA audit files are retained.
· Develop recommendations for corrective and preventative actions to respond to client visit and inspection findings..
· Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.
· Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
· Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
· May participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
· Assure the suitability of materials and supplies for compliance with specifications.
· Assist in developing and providing basic training to QA and operations personnel.
· Assist in scheduling and tracking QA audits, inspections and procedures as requested.
· Assist with review and revision of QA SOPs to reflect current practice.
· Participate in collecting and reporting of quality metrics.
· Perform all other related duties as assigned.
· quality assurance (1 yr preferred): 1 year (Preferred)
· manufacturing (2yrs required): 2 years (Required)
· High school (Required)
· An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
· Certification/Licensure: None.
Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing.
The strength of the business model is the supply of fabricated components to original equipment manufacturers, distributors, contractors and home centers throughout North America and Western Europe.
OmniMax InternationalOmniMax International, Inc. headquartered in Peachtree Corners, GA is an international building products company manufacturing aluminum, steel, vinyl and copper products. Core products include specialty coated coils, metal wall and roof systems, metal and vinyl rain carrying systems, soffit and fascia systems, roofing accessories, aluminum and vinyl windows and doors, patio products, aluminum recreational vehicle doors, windows and sidewalls and aluminum bath and shower enclosures. Products are then represented in the market by multiple brands such as Amerimax, Fabral and Euramax Coated Products. The strength of the business model is the supply of fabricated components to original equipment manufacturers, distributors, contractors and home centers throughout North America and Western Europe.