Highlights
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances. Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
Numbers & Facts
| Location | San Diego, CA |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1998 |
| Website | http://www.kyyba.com/ |
Description
Job Title: (Senior Document Control Specialist)
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Job Description
RESPONSIBILITIES:
Perform the role of Change Order Coordinator for the facility.
Independently facilitate the Document Change Order and Deviations including formatting, coordinating the review and approval process, tracking and routing controlled documents, and release of documents in a timely manner.
Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
Issue document numbers, lab notebooks numbers and part numbers.
Assist in drafting, formatting, editing and rewriting SOPs in support of the quality systems across the organization.
Ensure document reviews are performed periodically in a timely manner by Document Owners. Manage archiving, obsolescence and document storage.
Perform Document Control training for new and existing employees.
Support development of QA-related training materials.
Assist with training assignment and collection of training metrics in Metro.
Trend Document Control Metrics for Management Review.
Respond to queries and issues raised by Document Owners and Approvers in a timely manner.
Assist with internal and external audits.
Support the continuous improvement to the Quality Management System, with a specialty focus on document control and change order processes.
BASIC QUALIFICATIONS | EDUCATION:
Bachelor's Degree and/or an equivalent combination of education and experience.
2 years or more of experience in Quality Assurance or in Document Control, in a laboratory, medical device or similarly regulated industry.
Working Knowledge of 21CFR820, ISO 13485:2016 standard.
Experience processing changes using an electronic documentation system.
Experience with technical writing, formatting and trending of data.
Agile Document Management System experience preferred.
COMPETENCIES:
Proficient with Microsoft Office, including Word, Excel, PowerPoint, electronic document control tools and Visio.
Ability to understand QMS procedures and ability to recognize deviations from approved documented procedures
Self-starting, detail oriented, and ability to focus on task at hand
Ability to work independently with multiple departments to resolve Document Control issues
Must be able to work effectively in a fast paced, team-oriented environment
Well-developed English written and verbal communication skills
Location: (San Diego,CA)
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”
It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Job Description
RESPONSIBILITIES:
Perform the role of Change Order Coordinator for the facility.
Independently facilitate the Document Change Order and Deviations including formatting, coordinating the review and approval process, tracking and routing controlled documents, and release of documents in a timely manner.
Ensure that any new documents or changes to existing documents are appropriate, justified, accurate, complete, meets Good Documentation Practices, and approved by the required functional areas according to established procedures.
Issue document numbers, lab notebooks numbers and part numbers.
Assist in drafting, formatting, editing and rewriting SOPs in support of the quality systems across the organization.
Ensure document reviews are performed periodically in a timely manner by Document Owners. Manage archiving, obsolescence and document storage.
Perform Document Control training for new and existing employees.
Support development of QA-related training materials.
Assist with training assignment and collection of training metrics in Metro.
Trend Document Control Metrics for Management Review.
Respond to queries and issues raised by Document Owners and Approvers in a timely manner.
Assist with internal and external audits.
Support the continuous improvement to the Quality Management System, with a specialty focus on document control and change order processes.
BASIC QUALIFICATIONS | EDUCATION:
Bachelor's Degree and/or an equivalent combination of education and experience.
2 years or more of experience in Quality Assurance or in Document Control, in a laboratory, medical device or similarly regulated industry.
Working Knowledge of 21CFR820, ISO 13485:2016 standard.
Experience processing changes using an electronic documentation system.
Experience with technical writing, formatting and trending of data.
Agile Document Management System experience preferred.
COMPETENCIES:
Proficient with Microsoft Office, including Word, Excel, PowerPoint, electronic document control tools and Visio.
Ability to understand QMS procedures and ability to recognize deviations from approved documented procedures
Self-starting, detail oriented, and ability to focus on task at hand
Ability to work independently with multiple departments to resolve Document Control issues
Must be able to work effectively in a fast paced, team-oriented environment
Well-developed English written and verbal communication skills
Location: (San Diego,CA)
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”
It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
- An INC 5000 company for 10 years
- Corp! Michigan Economic Bright Spots
- Crain’s Detroit Business Top Staffing Service Companies in Detroit
- TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
- Best of MichBusiness winner in HR Wizards & Partnerships
- Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
- 101 Best & Brightest Companies to Work for in Michigan
About Company
Kyyba group of companies are privately held and specialize in staff augmentation, application software and project solutions. In operation for more than 15 years, we have earned an enviable track record and reputation within all the industries we serve. Our unique processes and maturity enables us to understand the needs of the business organizations and provide business solutions that match the real and compelling needs of our customers.
Headquartered in Michigan, Kyyba has multiple office locations and we serve local, regional and national client base consisting of Fortune 500 and middle market companies. Kyyba extends the above solutions and services to a broad spectrum of industry verticals ranging from automotive, insurance, technology, financial, transportation, government and so on.