Staffing Solutions Enterprises
QA Document Specialist
Location: Cleveland, OH, 44128
Salary: $38-44K, onsite
Hours: Monday - Friday, 8:30 am-4:30 pm
Permanent, full-time position
The QA Document Specialist is responsible for handling and reporting complaints, issuing device history records, maintaining all current Good Manufacturing (cGMP) documentation and other miscellaneous duties as assigned by Sr. Manager of Regulatory and Quality.
Essential Functions
Maintain the hard copy of documents as well as the electronic database of all Standard Operating Procedures (SOP), Specifications (SPEC), Test Methods (TM), Protocols and Validation documentation. This includes converting all documentation to PDF format. Review documents submitted for approval routing to ensure correct formatting, pagination, headers, attachments, forms, etc. Assist with the review, revision, and development of documents. Maintain database of electronic forms of effective documents that are used by employees for the collection for quality data. Organize and maintain the document storage area. Maintain both computerized and hard copy document systems including Device History Records (DHR), Corrective and Preventive Action (CAPA), Nonconformances (NR), Deviations, Engineering Change Control (ECR), etc. Address customer complaints, maintain hard copy and computer files of these records, and organize the replacement of defective products. Assist with trend analysis of customer complaints, production scrap, finished device inspection, etc. Issue product Device History Records (DHRs) for production of finished devices. Review completed DHRs and release finished device lots. Maintain both computerized and hard copies of training records. Maintain the electronic database of Approved Supplier List (ASL) as well as their associated files. Qualifications
High School Diploma to Associates degree or commensurate experience required. Background/Training/Skills/Experience
1-3 years of administrative or customer service experience. Strong verbal and written communication skills required. Strong interpersonal skills. Extremely organized and able to provide information quickly. Technically proficient in Microsoft Office Products and personal computer skills. Must be highly organized, accurate, and detail-oriented. Must be able to handle multiple projects simultaneously. Knowledge of cGMPs in the Medical Device and/or Pharmaceutical industry.
#LI-CF1 #SSEIND
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Staffing Solutions Enterprises, StaffMatrix, BV Staffing, and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at https://www.staffingsolutionsenterprises.com/privacy-policy/
The QA Document Specialist is responsible for handling and reporting complaints, issuing device history records, maintaining all current Good Manufacturing (cGMP) documentation and other miscellaneous duties as assigned by Sr. Manager of Regulatory and Quality.
Essential Functions
Maintain the hard copy of documents as well as the electronic database of all Standard Operating Procedures (SOP), Specifications (SPEC), Test Methods (TM), Protocols and Validation documentation. This includes converting all documentation to PDF format. Review documents submitted for approval routing to ensure correct formatting, pagination, headers, attachments, forms, etc. Assist with the review, revision, and development of documents. Maintain database of electronic forms of effective documents that are used by employees for the collection for quality data. Organize and maintain the document storage area. Maintain both computerized and hard copy document systems including Device History Records (DHR), Corrective and Preventive Action (CAPA), Nonconformances (NR), Deviations, Engineering Change Control (ECR), etc. Address customer complaints, maintain hard copy and computer files of these records, and organize the replacement of defective products. Assist with trend analysis of customer complaints, production scrap, finished device inspection, etc. Issue product Device History Records (DHRs) for production of finished devices. Review completed DHRs and release finished device lots. Maintain both computerized and hard copies of training records. Maintain the electronic database of Approved Supplier List (ASL) as well as their associated files. Qualifications
High School Diploma to Associates degree or commensurate experience required. Background/Training/Skills/Experience
1-3 years of administrative or customer service experience. Strong verbal and written communication skills required. Strong interpersonal skills. Extremely organized and able to provide information quickly. Technically proficient in Microsoft Office Products and personal computer skills. Must be highly organized, accurate, and detail-oriented. Must be able to handle multiple projects simultaneously. Knowledge of cGMPs in the Medical Device and/or Pharmaceutical industry.
#LI-CF1 #SSEIND
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Staffing Solutions Enterprises, StaffMatrix, BV Staffing, and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at https://www.staffingsolutionsenterprises.com/privacy-policy/