DO WORK THAT MATTERS:
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. We have an exciting opportunity for a QA Specialist III within our Immunalysis division located at Pomona,CA. In this role, you will be responsible for supporting the organization and maintenance of the system for controlling the generation and revision of all batch record documents for the company
* Maintain the finished product batch/lot number database.
* Issue batch records for production.
* Review labeling materials such as labels and product inserts for accuracy, legibility and completeness.
* Perform Batch Record review for release of in-process items and finished goods.
* Create and maintain COA for each finished good lot.
* Analyze data and compare with the existing specification in the batch record and QC test sheets.
* Maintain and organize all records by scanning and uploading documents and filing originals.
* Process deviation reports.
* Review change control documents and take appropriate actions.
* Perform line inspection: line clearance, in-process quality checks, handle test and retain samples.
* Act as Lead for the area: mentor and train other QA Specialists and/or QA Technicians.
* Perform complex tasks, projects or assignments as directed by the QA Supervisor: preparing metrics, performing audits, leading the QMS training program.
To be considered an applicant for this position you must show how you meet the basic qualifications of the job in a resume or document you upload, or by completing the work experience and education application fields. Accepted file types are Microsoft Word (DOC or DOCX), PDF, HTML, or TXT.
INTERNAL APPLICANT GUIDELINE:
* Please be advised that there is 5 calendar day window for internal employees to submit their applications and internal employees can not apply after 5 calendar day window is closed unless Hiring Manager requests to open the window again for more applications.
* Before you apply for an internal opportunity you should notify your direct manager.
* To be eligible for an internal transfer/promotion, you must be in your current position for at least a year and must maintain satisfactory performance in your current position and not be under a present corrective/disciplinary action.
* BS/BA in field of science such as Chemistry, Microbiology, Biology and Biochemistry.
* Minimum of 5 years of Quality Assurance document experience with IVD, Pharmaceuticals or Medical Devices preferred.
* Leadership/supervisory experience is desired.
* Knowledge of FDA QSRs and ISO 13485 requirements and GLP, GMP and GDP standards.
* Quality minded, pays attention to details, quick learner, works well with other departments.
* Able to notice complex issues, investigate root causes, resolve problems and suggest improvements.
* Great documentation practices and strong writing/verbal skills.
* Strong interpersonal skills and ability to work as a team player.
* Strong knowledge of computers and software programs including Word, Excel, Access, Powerpoint, and document management programs.
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 103,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to email@example.com.
Alere provides diagnostics and health management solutions for infectious, heart and cancer-related diseases and drug addicts.