Performs Document Control and Record Control activities, and provides administrative support for the Company’s Quality System.
MAJOR DUTIES AND RESPONSIBILITIES:
- Process Change Orders (COs) in a timely manner with high level of accuracy in compliance with company procedures.
- Collaborate with Change Order Initiators to ensure accuracy of the change orders.
- Ensure compliance with controlled document format and content.
- Ensure material dispositions are filled out accurately.
- Maintain Document Control and Quality System related document retention, databases and logs (e.g. laboratory notebooks, off-site records archival log, etc.).
- Participate in audit preparation and other audit related activities
- Perform distribution of controlled documents and retrieval of obsolete/superseded documents.
- Periodically inspect/audit controlled binders and training records to ensure accurate distribution and current training (i.e. correct documents and current revisions).
- Assist in maintaining the external standards library.
- Scanning, filing and maintenance of all types of quality system records.
- Assist in performing LHR reviews.
- Assist in executing software test scripts.
- Assist in generating training plans, entering training records and maintaining training database as needed.
- Perform other Quality System related duties as assigned.
- High school diploma. Associate or Bachelor’s degree preferred.
- Familiarity in Document Control or similar Quality Systems related role with at least 3 years’ experience in medical device, pharmaceutical, or related industry.
- Must be proficient with WORD, Excel, Power Point and Adobe.
- Must be able to work independently with minimum supervision.
- Organized and detail oriented.
o Must be organized and have strong attention to detail.
o Excellent communication and time management skills required.
o Ability to learn quickly and prioritize tasks in a fast paced and dynamic environment.
o Knowledge of FDA QSR/cGMP/ ISO 13485 is required.
o Proficiency with SolidWorks and Electronic Document Management systems preferred.
PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Job Type: Full-time
Salary: $65,000.00 to $70,000.00 /year
- GMP: 1 year (Preferred)
- Electronic system: 1 year (Required)
- Documenting: 3 years (Required)