What are the responsibilities and job description for the Document Control Specialist position at StatLab Medical Products?
Duties and Responsibilities (essential duties are italicized)
- Responsible for the implementation, maintenance and management of the Documentation Control system to ensure that all users have access to the latest revision of quality system and corporate documents, where applicable.
- Responsible for evaluation of Documentation requirements in adherence to FDA cGMP/QSR, and ISO 13485 regulations.
- Responsible for maintaining and implementing improvements to the Documentation Control processes, including but not limited to, Document Identification, revision and Change Control functionalities, storage, archival and backup, maintenance, and distribution.
- Review documentation to ensure existing documents meet approved format and template requirements.
- Implement improvements and procedures to improve quality of work and cost effectiveness.
- Coordinates the interaction between R and D/Engineering, Manufacturing, Operations, Sales and Marketing, etc. to ensure appropriate changes are documented and implemented.
- Manage and facilitate the training process by maintaining training matrixes, distributing and collecting training materials and forms, and tracking training compliance metrics.
- Evaluate documentation and training requirements in accordance with regulatory standards.
- Train employees on records management procedures and policies, which include documentation, retention, retrieval, and destruction. Train employees on good documentation practices, as needed.
- Tracks and trends the effectiveness of the overall document control system, including providing status of document changes and change control records.
- Assist with file retrieval, and assist/support internal and external audits.
- Assist in the hiring of additional resources, as needed, and manage any new subordinate positions.
- Attends all scheduled meetings, missing no more than 10% annually.
- Manages any stress on the job, including but not limited to meeting deadlines.
- Provides excellent customer service.
- Actively demonstrates teamwork at all times.
The duties described above are not inclusive. Additional duties may be permanently assigned or required
from time to time due to the need to respond to customer needs and remain competitive in the
marketplace.
Minimum Knowledge, Skills, and Abilities Required
- Bachelor’s Degree in a Scientific or Engineering discipline, or other relevant work experience required.
- Certifications specific to medical device quality and standards a plus.
- 5- 10 years of experience, including: working within Documentation and Quality Systems, in a medical device / biotech environment.
- Experience with implementing Quality Systems, with emphasis on electronic documentation systems.
- Experience in Quality Management Systems and their governing standards such as cGMP/FDA and ISO 13485 requirements.
- Experience with group presentations using PowerPoint.
- Experience with training at various levels on various documented areas.
- Ability to use Microsoft Office tools, Word, Excel.
- Ability to author procedures, work instructions, forms, records.
- Experience with internal audit practices.
- Excellent eye for detail.
- Strong verbal, written, and communication skills
- Ability to work with cross-functional teams and also work independently.
- Ability to meet deadlines as required and to perform multiple tasks.
- Demonstrates flexibility, i.e. - willingly takes on new tasks.
- Prioritizes projects and meets deadlines
- Ability to manage stress.
- Ability to meet physical demands of the job which include, but are not limited to: walking; bending; pushing; pulling; sitting for extended periods of time at a desk using a computer, phone and headset; and occasionally lifting and carrying items which may weigh up to 25 pounds.
- Position spends approximately 75% of time sitting at a desk and 25% standing or walking.
- Vision and hearing must be within or correctable to within normal range.
- Must work from the corporate office and be able to work on time on a regular basis during regular business hours and on-call during evenings and weekends as needed.
- \While performing the duties of this job, the team member is exposed to computers and general office equipment approximately 85% of the time. The noise level in that work environment is usually quiet. The other 15% of the time will be working in the production facility where the noise level is high.
This position is onsite in McKinney, TX. Salary is $45,000-$55,000 DOE Eligible for 5% Annual Merrit bonus
Experience
Required- Quality Management systems and their governing standards such as cGMP/FDA and ISO 13485 requirements
- Implementing quality systems with emphasis on electronic documentation systems
- 5 - 10 years: working within Documentation and Quality Systems in a medical device/biotech environment
Education
Required- Bachelors or better
Salary : $45,000 - $55,000