***This position requires long term eligibility to work in the US without sponsorship. Please note F-1 OPT Visas are not considered long term eligibility for this role.
In labs and health care facilities worldwide – HERE WE ARE
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose – to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
This position is at a client clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. The client’s suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates.
We are seeking a highly-motivated professional who is looking to grow their career. The Systems Specialist will generally support the Quality Systems team with a focus on the clean up of the electronic Document System (EDMS), Deviation/Change Control programs and may assist with the GxP Training Learning Management System (LMS). This position will be based in Seattle.
• Supports the Deviation and Change Control programs using the electronic Veeva Quality Management System (QMS).
• Assists Deviation/Change Control Specialist on follow up, reporting and metrics development.
• Work with Document Control to generate reports and follow up on document progress as they approach approval.
• Participates with Document Control regarding clean up activities on going in the Veeva QualityDocs vault.
• Understands and supports the Veeva “Quality Docs” document control system and the quality systems associated with GxP operations.
• Supports GxP Training Program through verification that new users are set up correctly in the LMS (Learning Management System) in proper roles and user groups.
• Initiates and follows up on new GxP Training request using IT ticket system.
• Assists in following up and collecting all Job Descriptions and Curricula vitae as part of maintaining Training Files.
• Utilizes quality tools to assist in compilation, tracking, trending, and communicating QMS metrics in presentations, reports, and dashboards.
• Supports the maintenance and improvement of Quality Systems processes in general and the delivery of Quality Systems projects.
• Participates in and may drive completion of investigations and corrective action implementation for identified quality systems issues including internal/external audits actions.
• Other duties/responsibilities as assigned
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It’s not just talk, our award-winning training programs speak for themselves.
Join PPD in our relentless pursuit of excellence – apply now!
Qualifications:Education and Experience:
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, and experience.
Knowledge, Skills and Abilities:
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
- Ability to establish and maintain effective working relationships.
- Working knowledge of GxP regulations and Quality Systems.
- Working knowledge of use of Microsoft Office suite.
- Strong organizational and communication skills.
- Understanding of basic scientific/technical concepts.
- Positive, enthusiastic, and customer service oriented.
- Previous experience with electronic quality systems (Veeva preferred) such as for document control, training, deviations and change control
- General knowledge of laboratory processes
- Problem solving skills
- Ability to train others
- Detail oriented
- Good editorial/proofreading skills
- Proficient with Microsoft Office software
- Strong written and verbal communication skills
- Ability to work in a collaborative team environment
Working Conditions and Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to lift and move objects up to 25 pounds
- Able to work upright and stationary and/or standing for typical working hours.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.