Quality Technician III- Document Control

How will you make an impact?

The Quality Technician for this team maintains a controlled documentation system and record retention processes. Prepares and reviews required documentation such as good manufacturing practices (GMP), procedure manuals, quality control manuals, engineering documents, manufacturing instructions, and change controls in accordance with company policy and government regulations. Coordinates the review and revision of procedures, specifications, and forms.

Job Responsibilities

• Maintains working knowledge of applicable regulatory requirements

• Participates in internal audits and external regulatory inspections

• Participates in the training of colleagues on the requirements surrounding documentation and records management

• Ensures documentation is current and available for use

• Receives and coordinates external customer documentation

• Oversees long-term storage of records 

• Acts as point of contact for retrieval of specific documentation, as required

• Reviews and maintains records retention schedules; and participates in maintaining compliance to Corporate and Site document and records management programs, systems and procedures

• Maintains and updates logs and/or databases used for tracking records

• Maintains controls over retrieval integrity of offsite storage

• Compiles data for reports

• Assists in preparing, reviewing, or auditing reports/documentation

• Processes documents: company policies and procedures, other documentation as required.

• Maintains department logs and generates reports.

• Provides customer service and support as relates to Document Control

• Assists in all Document and Records activities as required

• Supports Quality Systems audits, FDA, ISO, Internal, external etc.

• Provides training support as related to documents and records

• Compliance with safety policies and procedures

• Responsible for communicating business related issues or opportunities to next management level.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Creates new procedures, work instructions, quality plans, and other documents using the relevant QMS document management module

• Make changes to existing procedures, work instructions, quality plans and other documents using available systems tools

• Coordinates the revision, printing and distribution of controlled copies of quality plans, Visual Aids, work instructions and procedures. Etc.

• Assists in control of SOPs, cGMP, ISO 13485, 21CFR820 and FDA/Regulatory requirements.

How will you get here?

Education and Experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Must have at least 2 years of experience

• High School Diploma or GED preferred not required or equivalent experience.

• Proofreading/Grammar: Writes and proofreads written material with a high level of accuracy.

• Ability to manage a variety of projects assigned

• Presentations development skills

• Computer Literate: Windows, Microsoft Word, PowerPoint, Excel

• Adaptable: Ability to perform a variety of tasks, often changing assignments on short notice.

• Initiative: Self-starter, working well without close supervision.

• Strongly organized.

• Ability to handle multiple priorities

• ISO 13485 and QSR FDA standards knowledge

• Basic NWQS system knowledge

• Excellent communication skills

• Ability to work under minimum supervision

• Key attention to detail

• Team player

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.

Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.