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SalaryAbout the Role:
We are looking for a Regulated Quality Assurance Associate to join our team. In this role, you will partner with a business team as the Quality Assurance (QA) support Associate. In this role, you will also take on a broad range of responsibilities as a member of the Quality Assurance team. You will work with various cross-functional teams to ensure the appropriate interpretation of quality system requirements, while influencing the implementation of continual improvement through team concurrence and decision-making.
This position will be located at one of our facilities in Elkton, Maryland, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.
- Serve as Quality System Representative for product teams and shared PharmBIO quality system processes to ensure appropriate compliance as it relates to systems, processes, products, improvements, and modification
- Assure all quality system documentation and record keeping activities are carried out and completed in compliance with established procedures and work instruction
- Participate in internal, external, and supplier audits, as needed
- Ensure appropriate quality system process monitoring and trend response (Complaints, DCRs, CAPA, etc.)
- Write and revise documents and process through change control system, as required
- Assure quality systems compliance with internal procedures and external standards while identifying and driving key quality system process improvements
- Partner with cross-functional teams including, but not limited to, procurement, engineering, manufacturing, and regulatory affair
- Maintain compliance with training expectations as required for this position
- Additional responsibilities as required within the scope of position
Required Qualifications:
- Bachelor's degree in science or engineer OR a minimum 3 years' experience in a Quality Assurance or Quality Engineering role in an industry with high quality demands and regulation/customer requirements
- Track record of keeping commitments, owning, and driving improvements, and getting solid, tangible results
- Demonstrated mindset of continual improvement and track record of defining and achieving the desired future state
- Demonstrated excellent business judgment and decision-making skills
- Strong written communication skills
- Strong interpersonal skills (ability to teach and gain compliance alignment cross functionally)
- Demonstrated critical thinking (ability to understand the applicable standards, ensure compliance to them and identify opportunities to improve)
- Ability to travel up to 15%
Desired Qualifications:
- Previous experience auditing for internal compliance to Quality System requirements
- Demonstrated ability to leverage industry best practices; to understand ISO and GMP quality system principles; and to continuously learn and connect with evolving industry standards and best practices
What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
