About the Role
We are looking for a Document Controller to join our team at a facility in Elkton, Maryland. In this role, you will be responsible for managing the change and document control processes in PharmBIO’s Quality Management System. This includes monitoring electronic changes through the Agile PLM system, providing document control support (releasing and implementing approved documents, obsoleting and archiving documents) and supporting improvement projects as they arise.
This position will be located at our facility in Elkton, Maryland, with the possibility of a hybrid work arrangement. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.
Pay and Benefits:
- $30 to $42 per hour
- Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills and abilities.
- Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits. More details are available at www.gore.com/careers/benefits
Responsibilities
- Reviewing proposed changes with initiators to determine scope of the change and appropriateness of approvers, as defined by the PharmBIO Document and Change Control Procedure
- Owning the change management process and assisting users in processing changes through routing/approval flows, as needed
- Being responsible for continual improvement and consistency of the change control process
- Support the document management process, including processing of document related change orders and maintaining controlled copies as applicable
- Act as primary point of contact (Subject Matter Expert) for PLM support and troubleshooting
- Supporting associate training for the Document and Change Control process, including PLM system use, and maintaining software training materials
- Support PharmBIO's training program by executing routine tasks
- Maintaining change metrics and reports on a consistent basis
Required Qualifications
- Minimum 3 years of experience working within a PLM/Quality Management Software System
- Demonstrated aptitude for performing detail-oriented work, being well organized, and capable of organizing a diverse set of records
- Experience with a quality management system, specifically hands on experience with change management systems
- Demonstrated ability to make decisions in a fast-paced environment and an independent ability to set priorities with frequent interruptions
- Demonstrated ability to identify process performance gaps and drive continual improvement
- Demonstrated ability to coach and train others effectively, including training for a broad range of associates at various detail levels
Desired Qualifications
- Formal training or education in quality, operations management, or supply chain
- Demonstrated understanding of ISO and GMP quality system principles within a Medical Device, Pharmaceutical, and/or Bioprocessing manufacturing environment
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
Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to 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 protected 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 United States. Gore generally will not sponsor visas unless otherwise noted on the position description.
