Please be aware that, as a condition of employment, proof of COVID vaccination is required for all U.S.-based employees (subject to limited exceptions). To ensure the health and safety of all PacBio employees and our prospective candidates, we have instituted a virtual interview and onboarding experience.
Contractor - Document Control Specialist
Location: San Diego
The Document Control Specialist will perform a wide variety of activities pertaining to Document Control (DC), and Records Management in accordance with ISO 9001:2015 and ISO 13485:2016 requirements. Primary responsibilities will entail structuring and populating design and manufacturing applications with new/revised product information such as part numbers, bill of materials, and other product related information received from various cross-functional customers via the Change Order process. Carrying out daily operations of the DC function, as well as supporting project teams in meeting quality and business objectives. Assisting the DC Manager in instituting various integration implementation initiatives ensuring alignment and synchronization between sites. The ideal candidate should possess the technical aptitude and knowledge to work within these structures, functions, and applications to efficiently support a high-volume Medical Research, Development and Manufacturing environment.
- Will assist in the entry and maintenance of all product documentation, as well as ensure timely, thorough, and accurate release of Change Orders (CO's), and Manufacturing Change Orders (MCO's) processed through Agile PLM and SAP.
- Ensure processes for maintaining controlled quality system and product documentation in electronic format is well defined to meet Pac Bio's business management system requirements.
- Ensure accuracy and integrity of data is maintained in all Document Control databases (Agile/SAP/LMS).
- Working closely with the QA and other cross-functional departments ensure training section of affected P/N's residing on COs is accurate and complete.
- Lead and manage Change Control Board (CCB) meetings if required.
- Will support DC customers located in various sites to achieve targeted product launch schedules.
- Will provide relevant DC key performance indicators (KPI) data.
- Ensure processes for maintaining controlled quality system and product documentation in electronic/hard copy format are well defined to meet company business management system requirements (e.g., drawings, procedures, quality system records, bills of materials, specs, technical literature, etc.)
- Will assist in performing Agile Product Lifecycle Management (PLM) training and other departmental training as requested by DC Manager.
- Will develop and review procedures, and other quality system documentation ensuring adherence to Good Manufacturing Practice (GMP), ISO standards.
- Provide administrative/project support related to Document Control as assigned by DC Manager.
- Knowledge of medical device regulations and standards such as ISO 9001:2015 and ISO 13485.
- A thorough understanding in use of PLM, ERP, LMS applications (i.e., Agile, SAP, Compliance Wire).
- Direct hands-on experience with processing Change Orders, preferably using Agile PLM.
- Ability to design and develop written instructional materials, procedures, and guidelines of the highest quality.
- Strong background in revising, reviewing, and processing discrete and process BOMs and drawings (i.e., schematics, PCB, Software, etc.).
- Strong skills in creating and maintaining required Document Control departmental metrics.
- Demonstrated ability to follow instructions/schedules/timelines and handle multiple priorities in a cross-functional dynamic environment with minimum supervision.
- Demonstrated ability to train, provide feedback and re-train employees.
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
- Strong working knowledge of Adobe Acrobat, and MS Office - especially Word, Excel, and Visio.
- Ability to work in a high volume fast paced environment with minimal instruction on routine work, and general instructions on new assignments.
- Ability to implement departmental process improvement recommendations that will support the strategic business goals and departmental goals/objectives.
- Excellent interpersonal and communication skills (verbal and written) combined with a sincere passion for enabling others through training.
- Must be a self-starter with a strong focus on quality and exercises good judgment within broadly defined practices and policies in selecting methods, techniques, and criteria for obtaining results.
- 3+ years demonstrated experience and expertise in Document Control coupled along with excellent problem solving and troubleshooting skills.
- BA degree preferred
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or based on disability, gender identity, and sexual orientation.