Specialist, Document Control
JenaValve
Job Title Specialist, Document Control Role Level: Individual Contributor (IC)
Supervisor/Manager Title: Manager, Corporate Documentation Change Job Location & Environment: Irvine, CA - Corporate Office Environment Job Description Summary: Coordinates, implements, and maintains the company's Document/Change Control and Training Management systems. Follows established procedures and policies needed to meet the demands of document control in a regulated medical device company. Support company goals and objectives, policies and procedures, Quality System requirements, and all applicable regulations. Job Responsibilities:
Supervisor/Manager Title: Manager, Corporate Documentation Change Job Location & Environment: Irvine, CA - Corporate Office Environment Job Description Summary: Coordinates, implements, and maintains the company's Document/Change Control and Training Management systems. Follows established procedures and policies needed to meet the demands of document control in a regulated medical device company. Support company goals and objectives, policies and procedures, Quality System requirements, and all applicable regulations. Job Responsibilities:
- Processing of controlled documents and items approved via change control system including, but not limited to:
- Review change orders and non-change order type documents to ensure compliance to company document and change control procedures.
- Incorporation of document changes and release of all current and inactive controlled documents in hard copy and electronic formats.
- Verification of completion of DCO-related activities, such as material disposition and training, to ensure closure of DCO following completion of these activities.
- Creation and maintenance of Items, BOMs, and Routings in ERP system to support operations.
- Distribution of copies of the latest revisions of controlled documents to control locations.
- Destruction of copies of the outdated revisions of controlled copies, as required.
- Maintenance of controlled documents in such a manner as to prevent loss or damage, and to allow future access, including hard copy of electronic back-up files and/or fireproof file cabinets.
- Maintenance of index of current controlled documents.
- Provide training to Document / Change Control System and processes to internal customers, as required.
- Review Quality Records for adherence to Good Documentation Practices (GDP) and compliance to governing procedures, as applicable.
- File and maintain quality documents and records, including but not limited to DCO's, controlled document masters, test protocols and reports, Design History Files, Device History Records, Lab Notebooks, and other Quality Records. Ensure documents and records are retained per company procedures.
- Coordinate archiving of controlled documents and quality records to off-site storage.
- Monitor and track site personnel training compliance and file associated training records. Send reminders to employees for overdue training.
- Actively support and occasionally lead (as required) changes to Document and Change Control processes and documentation as required.
- Support QA in preparation of an internal and external audits/regulatory facility inspections.
- Perform other duties as assigned by supervisor.
- A high school degree is required. Minimum of 3-5 years' experience in Document Control within the medical devices, pharmaceutical or other regulated industry. Medical device is preferred.
- Understanding of 21CFR820 and ISO 13485 quality system requirements.
- Prior experience with ERP and electronic Document Control & Training Management systems.
- Takes initiative, self-starter, and the ability to conduct hands-on work with minimal supervision.
- Proficient with MS-Office applications - Word, PowerPoint, Excel - and PDF applications such as Adobe PDF.
- Work effectively and collaborate within cross-functional teams.
- High attention to detail.
- Ability to read and understand documents. Familiarity with bills of materials.
- Ability to file and organize records. Knowledge of document scanning and printing equipment; ability to utilize electronic files.
- Good oral and written communication skills.
- Prolonged sitting
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Specialist, Document Control in Irvine, CA vacancy
$76.8k - $90.36k
...Continuous Improvement Specialist II Collectors is the leading creator of innovative... ...quality, cost effectiveness, and risk control. You will apply professional judgment within... ...cross-functional participation, and documenting outcomes and controls to improve safety...SuggestedFull timeWork at officeWorldwideFlexible hoursShift workCollectors Universe
Santa Ana, CA3 days ago- ...Specialist, Document Control Irvine, CA – Corporate Office Environment Job Description Summary Coordinates, implements, and maintains the company's Document/Change Control and Training Management systems. Follows established procedures and policies needed to...Suggested
JenaValve Technology, Inc.
Irvine, CA3 days ago $35 per hour
...General Information Name Purchasing Specialist Employment Type Temporary Position level... ...preferred. Knowledge of ERP system being a SME is a plus , Document Control System and Excel Experience working in a highly matrixed...SuggestedFull timeTemporary workWork at officeLocal areaImmediate startRemote workDay shiftKelly Services, Inc.
Irvine, CA2 days ago$35 per hour
Purchasing Specialist - Irvine, CA Kelly Services is seeking a Purchasing Specialist for a long-term position with one of our Global... ...preferred. Knowledge of ERP system being a SME is a plus, Document Control System and Excel. Experience working in a highly matrixed...SuggestedFull timeLocal areaDay shift$75k - $90k
...Job Description Job Summary The Project Specialist is a critical role within the Marcom group and is responsible for the tactical... ...Upload, steward, and manage approvals within the document control system (Agile) Facilitate weekly approval meetings...SuggestedWork at officeLocal areaFlexible hoursMasimo
Irvine, CA1 day ago- Accounts Receivable Specialist Orange County, CA • Contract • Accounting Operations • $35/HR - $38/HR • Expiring 04/2... ...and support month‑end close and reconciliation tasks. Document workflows, support internal control practices and assist with continuous improvement...Contract work
$77.11k - $100.23k
...matter expert (SME) of cash management activities (Wires, ACH’s, controlled disbursements, tax payments, FX trades, cash positioning and... ...for all payment methods, securing all required substantiating documents. Review of new bank information Prepare the monthly journal...Work experience placement- Merical Inc. in Anaheim, California, is seeking a Gummy R&D Document Control Administrator to maintain vital R&D documentation and ensure seamless operation within various departments. The role requires strong organizational and mathematical skills, along with the ability...
$25 - $30 per hour
MeriCal®, located in Anaheim, California, is seeking a Gummy R&D Document Control Administrator to manage critical R&D documents crucial for manufacturing operations. This role includes creating raw material specifications, collaborating with Gummy Formulation Scientists...Hourly pay$77.7k - $146.9k
...financial,operational, and/or information technology,internal controls, identifying risks and related controls, as well as performing... ...~ Perform technology risk assessments and reviewing, documenting, evaluating control's design and operating effectiveness, IT internal...Work experience placementInternshipLocal areaRSM US LLP
Irvine, CA3 days ago- ...Associate Tech Specialist Our challenge is to use modern tools, techniques, and methods to develop, modify, and/or update complex... ...repair to prevent application outages Create and/or update documentation to support development efforts. Documentation may include detailed...
Keylent Inc
Irvine, CA3 days ago $77.8k - $97.3k
...starting Workplace Operations Associate Specialist to support daily operations and... ...tools, and standards by sharing feedback, documenting learnings, and piloting new approaches... ...Google Suite ticketing platforms, access control/badging systems, and communication tools...Full timeContract workTemporary workPart timeWork at officeLocal areaShift workRivian
Irvine, CA2 days ago$68k - $96k
...Associate Specialist, Event Coordination Innovation starts from the heart. Heart valve... ...expense reconciliation, invoicing support, documentation, and reporting. Coordinate calendars... ...& Safety rules) and take adequate control measures in preventing injuries to themselves...Work experience placementEdwards Lifesciences
Irvine, CA2 days ago- Solution Architect/Tech Lead Solution architect/Tech lead's primary responsibility is to design and develop a strategic API based middleware platform with React Frontend. The Solution Architect will work closely with business and technology partners to design and implement...
Keylent Inc
Irvine, CA3 days ago - ...Enrollment Specialist AmeriPharma is a rapidly growing healthcare company where you will have the opportunity to contribute to our... ...walk; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and stoop, kneel, crouch or crawl....Casual workInternshipMonday to FridayShift work
AmeriPharma
Laguna Hills, CA4 days ago - ...Family Medicine Specialist - MD Experience Life and Medicine in the Enchanting City of Santa Ana, California What if your next career opportunity could redefine not just your professional path but your personal lifestyle? In Santa Ana, where sun-soaked parks merge...Work at officeLocal areaRelocation package
MLee Healthcare Staffing and Recruiting, Inc
Santa Ana, CA2 days ago - ...Job Description Job Description The Behavioral Health Specialist provides behavioral health services to patients of all ages at... ...conferences to continue professional growth and development. Documentation Complete clear and defensible documentation of patient...Part timeWork at officeLocal areaImmediate startMonday to FridayFlexible hoursWeekend workAfternoon shift
Camino Health Center
Lake Forest, CA13 days ago $4,458.13 - $6,002.53 per month
...until filled and may close at any time. The City of Tustin Police Department is currently seeking applicants for Police Records Specialist. To be considered, a city application, supplemental questionnaire, AND typing certification (40 nwpm) must be submitted . For typing...Full timeGovernmentJobs.com
Tustin, CA5 days ago- ...Connections in Sunny California - Your Future as a Speech Pathology Specialist Awaits! Overview Imagine a career where your daily... ...along the treatment journey. Keep detailed and timely documentation that meets state, federal, and organizational requirements....Local areaImmediate startFlexible hours
MLee Medical Employment
Irvine, CA4 days ago - Job DescriptionPosition Purpose:The Asset Protection Specialist is primarily responsible for preventing financial loss caused by theft and fraud and supporting safety and environmental program compliance in their assigned store/multiple stores. They
Home Depot
Tustin, CA2 days ago - ...modifications, cancellations, and special travel requests.Provide accurate and up-to-date information regarding destinations, travel documentation, and agency processes.Follow up with clients to confirm travel plans and gather feedback post-trip.Address concerns with empathy...Remote work
Enchanted Horizons Travel
Irvine, CA1 day ago $90.5k - $115.5k
...Physical Therapy Specialist Santa Ana, CA $90,500 - $115,500 a year Full Time Job Description Imagine a place where your expertise... ..., and requisite home exercises, but you will also diligently document evaluations, treatment progress, and meet all regulatory...Full timeFlexible hoursMLee Healthcare Staffing and Recruiting, Inc
Santa Ana, CA10 days ago- ...Help us succeed as our next PayPal Dispute Resolution Specialist to perform responsibilities as a Dispute Resolution Specialist. Stay adaptable to changing priorities and business needs. Ensure compliance with safety and company policies. Perks include competitive pay...Flexible hours
TradeJobsWorkforce
Santa Ana, CA1 day ago - ...Position: Destination Specialist Company Overview: True Adventure Travel is a leading travel company that specializes in creating unique and unforgettable travel experiences for our clients. We are dedicated to providing personalized and high-quality services to our customers...Remote workFlexible hours
Next Stops travel
Irvine, CA1 day ago $20 - $25 per hour
...We light them up. About the Opportunity As a Behavior Specialist, you’ll: Use play, games, and evidence-based strategies to... ...diverse populations Willingness to complete training and documentation Ability to frequently sit and stand; keeping pace with your...Hourly payFlexible hoursAfternoon shiftWeekday workCenter for Social Dynamics
Santa Ana, CA3 days ago$95.88k - $113.18k
...Occupational Therapy Specialist - OTR/L Santa Ana, CA $95,880 - $113,180 a year Empower Lives as an Occupational Therapy Specialist... .... Track and Report Progress: Monitor clinical outcomes, documenting developments and making adjustments to treatment plans as...Full timeLocal areaFlexible hoursMLee Healthcare Staffing and Recruiting, Inc
Santa Ana, CA2 days ago$23.5 per hour
...Job Description Position Purpose: The Asset Protection Specialist is primarily responsible for preventing financial loss caused... ...responsibilities include: preparing accurate and detailed case reports documenting your apprehensions and recoveries, preserving evidence,...Local areaHome Depot
Irvine, CA1 day ago$388.38k
...Occupational Medicine Specialist - Orange County Primary Location: USA-California-Irvine Minimum Salary: $388,375.00 Maximum Salary: $405,039.00 Potential Premium Earnings: $15,696.00 Virtual Indicator: Standard Face to Face About SCPMG Competitive...Full timePart timeLocal areaRelocation packageSCPMG Meetings and Events (KPSymposia)
Irvine, CA1 day ago- ...ARDMS Certified Sonography / Ultrasound Specialist Experience transformation in the coastal jewel of Southern California: where every scan tells a story. Have you ever envisioned blending your sonography skills with life in a vibrant city ensconced amidst sun-kissed...Local areaFlexible hoursWeekend workDay shift
MLee Healthcare Staffing and Recruiting, Inc
Santa Ana, CA5 days ago - ...Registration Specialist The Registration Specialist supports the development of course schedules and the registration of students each session. The Registration Specialist aligns the course schedule with student class needs, qualified and approved faculty, and room...Work at office
Westcliff University
Irvine, CA8 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Specialist, Document Control. Be the first to apply!
Related searches
- protection specialist Irvine, CA
- mental health specialist Irvine, CA
- community outreach specialist Irvine, CA
- registration specialist Irvine, CA
- accessibility specialist Irvine, CA
- intake specialist Irvine, CA
- bilingual specialist Irvine, CA
- governance specialist Irvine, CA
- candidate experience specialist Irvine, CA
- word processing specialist Irvine, CA