Document Control Specialist I #1025100
Job Description:
SUMMARY:
The Documentation Clerk is responsible for providing clerical and administrative support for Quality Assurance documentation systems under current Good Manufacturing Practices (cGMP). Main responsibilities include electronic archival of Manufacturing Device History Records (DHRs), including scanning, verification, archival, and transfer of DHRs according to established procedures. Operation of a desktop computer using word processing software and document scanning equipment with applicable software are required competencies,
 
ESSENTIAL FUNCTIONS:

• Assist the Quality Assurance function with Record archival, storage, and destruction, while ensuring compliance with established regulations and standards.
• Preparation of DHR records including removal of staples, ensuring accurate pagination, and compilation of Device Serial Number and Software Version information for transfer to Global Servicing Platform (GSP), as needed.
• Scanning of DHR records using dedicated equipment with applicable software to produce a “true copy”.
• Verification of scanned copies as true copies i.e. verified to be clear, complete, and legible.
• Perform record archival or destruction according to the Records Retention Schedule and/or established procedures.
• Assist in troubleshooting of document scanner related issues.
• Maintain Document filing and archiving including filing of records checked in to Document Control and transfer of filed records to offsite storage, as needed.
• Perform other duties as assigned

 
QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED:

• Must have basic knowledge of office equipment.
• Working Knowledge of computer operations and a familiarity with applicable software packages (Microsoft Office Suite)
• Verbal and written communication skills
• Ability to pay attention to detail and prioritize workflow is essential.
• Strong Organizational skills
• Ability to multitask and perform tasks efficiently with little or no supervision.
• Ability to identify errors or faults in process and escalate issue to appropriate personnel when necessary.
• Able to demonstrate responsiveness to customer needs, within job scope.
• Ability to follow specific directions and complete routine tasks within provided guidelines.

 
EDUCATION/EXPERIENCE REQUIRED:

• High School diploma or equivalent.
• Minimum one (1) – two (2) years office experience preferred.
• Basic computer and word-processing skills.
• Clerical Skills desirable.

 
PHYSICAL DEMANDS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee:
  • Must be able to sit, stand, bend, stretch and walk throughout the workday
  • Must be able to lift at least 25 lbs.
  • Work well under tight deadlines

 
WORK ENVIRONMENT:

• Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
• Wear a static protective smock and Personal Protective Equipment (PPE) at all times while in the designated work areas.
• Work in close proximity to other employees.
• Work in an environment that is temperature and humidity controlled.

 
Additional Info:
 
At FastTek Global, Our Purpose is Our People and Our Planet. We come to work each day and are reminded we are helping people find their success stories. Also, Doing the right thing is our mantra.  We act responsibly, give back to the communities we serve and have a little fun along the way.
We have been doing this with pride, dedication and plain, old-fashioned hard work for 24 years!
FastTek Global is a financially strong, privately held company that is 100% consultant and client focused, operating in nearly half of the states in the U.S., Europe and India.
We've differentiated ourselves by being fast, flexible, creative and honest. Throw out everything you've heard, seen, or felt about every other IT Consulting company. We do unique things and we do them for Fortune 10, Fortune 500, and technology start-up companies.
Our benefits are second to none and thanks to our flexible benefit options you can choose the benefits you need or want, options include:
 

• Medical and Dental (FastTek pays majority of the medical program)
• Vision
• Personal Time Off (PTO) Program
• Long Term Disability (100% paid)
• Life Insurance (100% paid)
• 401(k) with immediate vesting and 3% (of salary) dollar-for-dollar match

 
Plus, we have a lucrative employee referral program and an employee recognition culture.
FastTek Global was named one of the Top Work Places in Michigan by the Detroit Free Press in 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, and 2023!
To view all of our open positions go to: https://www.fasttek.com/fastswitch/findwork
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