About the Role
Key Responsibilities:
- Process the creation and revision of controlled documents in Master Control.
- Assists in MasterControl (EDMS) user account set-up, maintenance, and retirement.
- Assists in preparing reports regarding quality and training activities.
- Run reports and generate metrics as directed.
- Provide assistance and training with document, training, and record management processes.
- Create and maintain public organizers in MasterControl, as directed.
- Maintain job code, course, classroom, trainer, exam, and trainee data.
- Responsible for the physical and/or electronic archiving and retrieval of records including sending records to offsite vendor.
- Retrieve records in support of audits and other business needs and ensure traceability and integrity of records.
- Ensure job descriptions, CVs, license, and certifications are appropriately maintained.
- Note: Other duties may be assigned.
Essential Requirements:
- B.A. or B.S. preferred. In lieu of degree, will consider equivalent work experience that includes 2 years of direct document control/quality/GMP
- 2+ years of direct document control experience in a regulated industry preferred.
- Experience with document control activities and/or MasterControl is preferred;
- Effective knowledge of maintaining a document and data control system
- Effective organization and planning skills.
- Requires strong written, oral, interpersonal, and communication skills.
- Demonstrated ability to deal with frequent changes, delays, or unexpected events.
- Must be able to follow established policies and procedures, and comply with regulatory requirements.
- Demonstrated ability to perform detail-oriented work with a high degree of accuracy and completeness.
- Must be an expert user of Microsoft Word and Excel.
The pay range for this position at commencement of employment is expected to be between $33.32 and $49.95 per hour; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Role Requirements
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