Documentation / Systems Technician (2 positions)
Job#: 2001796
Job Description:
Documentation / Systems Technician (2 positions)
These roles will start as soon as qualified candidates are identified. It will be working onsite at our Phoenix facility and work with our growing, national team!
Position Summary:
Performs data entry and report generation in various Quality Systems (Electronic Document Management System, Asset Management System, CAPA Database, Learning Management System) to support Business Units. Supports internal site compliance to applicable regulations, standards and quality systems through direct interactions across operations. Assists in the maintenance of company policies and procedures to ensure regulatory compliance.
Operates in accordance with company policies and procedures, FDA Regulations, USP , ICH and ISO Standards, where applicable.
Responsibilities: Essential Duties
Conducts activities related to the support of the training function. Performs training data entry in the Learning Management System
- Assists in Proficiency test administration and grading of tests, as necessary.
- Scans and stores training records according to records retention procedures.
- Provides feedback on system functionality / issues to the Quality System Manager
- Back up for 503B Training Coordinators, as needed.
- Conducts activities related to asset management:
- Performs data entry in the asset management tracking system, to include asset and schedule creation and maintenance of the asset in the system, including information from vendor calibrations, capturing as found and as left conditions of equipment.
- Scans and stores date equipment records in the Document Management System
- Conducts activities related to Quality Event Management and Quality Event Database Management:
- Issues quality event numbers to sites
- Provides related data to required Quality Units for investigation and analysis of quality events.
- Executes closure activities to include closing the event in the database and records retention of supporting data.
- Provides support in collaboration with Operations and other Quality Units for the identification and resolution of quality system process gaps.
- Provide support to all CAPS groups on good documentation practices, document control requirements and documentation processing.
- Assists in the review and update process for Quality Systems related procedures.
Expertise: Qualifications - Experience/Training/Education/Etc
- Some experience in Pharmaceutical/medical device industry preferred but not required
- Strong skills in Excell, Outlook, and data management programs
- HS or GED is required
- BS degree in technical or scientific discipline is a plus but not required
Expertise: Knowledge & Skill Requirements
- Develop working knowledge of USP, FDA/cGMP, ISO, and ICH requirements
- Conducts activities related to Quality Event Management and Quality Event Database Management:
- Excellent computer and PC skills including experience with MS Office applications/databases
- Must be able to effectively work with all functional groups.
- Strict attention to detail required. Problem detection ability a must.
- Ability to act effectively as a team member to resolve problems.
- Effective verbal, written and interpersonal skills
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.