Quality Systems Specialist II - United States
- This position will perform activities related to Quality Notifications, CAPAs and Effectiveness Checks within the QMS.
- Various QMS tracking, data entry assignments. Reviews and compiles device history records for accuracy and completeness, and to ensure adherence to in-house specifications and regulatory requirements. Documents deviations as appropriate.
- May perform activities related to one or more quality assurance functions including batch record review, product release, assisting with document inquiries and retrieval of archived documents and records, electronic records, SAP transactions, and posting of CofAs.
- Maintain and archive controlled documentation and completed quality records.
- Provides support during external audits or inspections. Administers investigation and deviation systems for tracking status, follow-up and liaison with applicable department investigation writers. Works with operations personnel to continually improve quality procedures and methods.
- Assists with supporting internal and external audits and investigations.
- Analyzes and prepares data for reports and recommendations for management reviews. Assists with Quality System projects as necessary.
- Supports databases and systems used for tracking various QMS activities. Supports and execute Document Control and ECR/ECO change processes.
What's in it for you?
- Competitive pay and great benefits including medical, dental, vision, 401K, and more!
- Opportunities for growth and training.
- Stability of a profitable 60+ year old company.
- Great work environment.
- Understanding of GMP and quality system standards as they apply to products manufactured by our company.
- Good organizational skills, including the ability to manage multiple projects simultaneously, with follow-through and ability to meet defined deadlines.
- Strong interpersonal skills are necessary to operate in a team environment to interact with multiple departments under a variety of conditions
- Microsoft Office applications including Word and Excel are required. SAP and Visio experience is a plus.
- Detailed oriented and ability to multitask.
- Decision making, time management, organization, communication, and leadership.
- Education: Associate degree or equivalent in Biology, Chemistry, or related field.
- Alternatively formal training that demonstrates a possession of and competency in the requisite knowledge, skills, and abilities to successfully perform the duties and responsibilities of this position.
- Experience: 2+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Preferred candidates should have experience working under FDA regulations and ISO standards.
- Relevant experience in document creation and managing Document Control functions within a document management systems and product life cycle systems.
- Strong technical writing background is a plus.
- Our company is a global leader providing a broad array of clinical diagnostics and life science research products.
- With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
- Our company was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better result
- EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age