Quality Assurance Specialist (Data Management)
|Lancaster, South Carolina - United States
$40,000.00 - $60,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Temporary Quality Assurance Specialist, Data Management to join our growing team. The position will be an SAP Expert for the site. The Quality Assurance Specialist, Data Management will be responsible for working within the Quality Systems organization supporting the development and implementation of harmonized processes and systems. Responsibilities within SAP will include site administration and integrity of all data related to Quality Systems at the site including, but not limited to, document management, user account management and troubleshooting. This position will also help evaluate, manage and document changes related to materials and suppliers. This position will actively participate in global procedure harmonization and other Quality System projects as needed.
Responsibilities include but not limited to:
- Maintain quality system controls to ensure state of compliance and no critical and major market complaints.
- Take appropriate steps to reduce wastage and losses in the analysis process and build improved efficiency.
- Serve as SAP Expert for the site; site administration and integrity of all data related to Quality Systems at the site including, but not limited to, document management, user account management and troubleshooting.
- Coordination of new vendors, materials, etc. in paper system and in SAP.
- Document systems and processes for supplier management to ensure compliance with internal, FDA and regulatory requirements.
- Help establish systems for tracking progress and providing updates for key processes and projects (material extension, SAP material code creation, vendor qualification, quality information records, material change activities, etc.).
- Perform documentation review as needed.
- Manage vendor and other documentation within QA to ensure compliance with internal procedures and regulatory requirements.
- Support business unit and corporate harmonization initiatives as they pertain to the quality management system.
- Develops applicable Standard Operating Procedures (SOPs) governing Quality Management Systems.
- Supports regulatory inspections and audits.
- As appropriate, use knowledge and experience to solve straightforward problems.
- Ensures all documents are easily retrievable.
- Ensures Quality Systems are compliant with SOPs.
- Use independent judgment, as necessary, in developing systems/processes for use within Quality Systems.
- Ensure Quality Management Reviews are performed per SOP.
- Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target.
- Associates degree in scientific discipline or closely related technical field of study
- Pharmaceutical and FDA is preferred.
- GMP experience is required.
- Previous Quality experience is preferred.
- Any quality certifications a plus
Knowledge & Skills:
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Strong organizational, analytical, troubleshooting and problem-solving skills. Ability to analyse details and perform structured decision-making on a daily basis.
- Excellent verbal and written communication. Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. Knowledge of LIMS (Laboratory Information Management System) and/or SAP (Systems, Applications & Products in Data Processing) or similar ERP systems is a plus.
- Good communications skills, front runner, GMP trainer a plus.
University - Associate's Degree/Graduate Diploma/2 Years