Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Job Title
QA Change Specialist
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
· An excellent retirement savings plan with a high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
We are recruiting for a QA Change Specialist to join our team within our Infectious Disease Developed Markets (IDDM) business unit located in Scarborough, ME. In this role you will assist in design change implementation, perform First Lot to Stock (FLTS) reviews, draft internal Notifications of Change (NOC), Track and coordinate changes, coordinate with planning for change implementation into production, and assist in label changes.
What You’ll Work On
Change Control Management (primary)
- Change Management Documentation
o Assignment of Design History File numbers
o Compile and maintain quality system records associated with design change projects, including project definitions, first-lot-to-stock, product qualification records, etc.
o Ensure records for design change projects are complete and align with SOPs.
o Manage organization, storage, and archival of documentation and records associated with design changes and labeling.
- Labeling Process Administration:
o Provide proofreading of product labeling prior to team review and approval.
o Initiate, execute and implement label changes in coordination with interdepartmental and external stakeholders.
- Change Control Execution:
o Assist with implementation of product changes, in conjunction with project leads.
o Manage assigned Design Change projects (Typically associated with product labeling)
- May participate in the internal audit program.
- Write, review and approve Standard Operating Procedures (SOPs) as necessary.
- Assist with and may write, review, and approve validations/test protocols as necessary.
- Provide backup to other Quality Specialists.
- Initiate and author Design Changes, Production Process Changes, or QMS Changes as necessary.
- Initiate and author Deviations and Quality Incidents (QI) as necessary.
- May administer the Document Control program.
- May administer the Quality Records program and assist and act as backup to the Document Control Specialist II (with administrator rights in site electronic documentation system).
- Train new and current Quality Assurance Technician and Specialists as needed.
Required Qualifications:
- Bachelor's Degree in Biology, Chemistry, Life Sciences, or another related technical field
- 3+ years of experience performing similar responsibilities in a Quality Assurance role within a manufacturing environment.
- Demonstrated ability to understand and adhere to quality documentation and excellent writing skills – must be able to summarize complex issues in a clear, succinct, and accurate manner and be able to write in a manner that effectively conveys complex issues to the reader.
- Excellent verbal and written communication skills, with ability to communicate to all levels of the organization.
- Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization.
- Proficient in MS Office (Word, Excel, PowerPoint, Outlook)
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.
