FDA Certified Documentation Control Specialist
We have an immediate opening for a FDA Certified Documentation Control Specialist for our Deerfield Beach, Florida facility.
Our company provides design verification, final assembly, labeling and packaging services of drug delivery devices, to the pharmaceutical and biotechnology industries and soon clinical fill finish capabilities. Scientists and Engineers work closely with our partners to continuously create and introduce innovative, patient centric, solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their counterparts at the partner company to develop and maintain program timelines in line with the strategic and business needs of our partners. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved as well as have one clear point of responsibility.
We are looking for a Document Control Specialist to assist in the maintenance of the Quality Systems at SHL Pharma by performing the following duties:
- Maintain controlled spreadsheets, master lists of documents and up to date files for the following Quality Systems: Change Order (ECO), Suppliers (Reports, Lists, SCARs), Quality Operating Procedures (QOP’s), Batch Records, Drawings, (DWs) Quality Work Instructions (QWI’s), Investigations and Corrective Action and Preventive Action (CAPA), Audits, Training, Design History File (DHF), External documents, and Complaint Handling.
- Prepare, issue, scan, and file quality documents such as Standard Operating Procedures (SOPs) Qualification and validation protocols, batch records, labels, logbooks, and training records.
- Record data, track errors and departmental metrics. Prepare reports for site management on open deviations/CAPA status, open change controls, training status, and site quality metrics, as required.
- Maintain quality, regulations and compliance information as part of a GMP library and the back-up archive for company.
- Provide necessary support for client audits and site regulatory inspections.
- Can work with minimal supervision.
- Performs other duties as assigned.
- College degree with at least 3 years of experience in the medical device field. Knowledge of FDA QSR requirements and ISO 13485, as they relate to document control is an absolute must.
- Must have good verbal and written communication skills and be able to work in a team environment.
- Must be detail-oriented and able to work with a high volume of documents in a fast-paced environment. They have to be highly organized and process-oriented. This position interacts with operations and engineering departments to collaborate on processes, procedures and documentation.
- Microsoft Office experience is a must.
We have an excellent benefits package and offer a salary that is based on experience and accomplishments.
If you possess the required experience and qualifications and want the challenge of growing with our company then submit your resume in confidence to our Human Resources Department at RecruitUS@shl-group.com