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Sr. Specialist, Quality Systems
5980 Horton St Suite 550 Emeryville, CA 94608 US
Job Description
Ideal candidates will have prior experience partnering with internal departments to support Document Control (eDMS), Learning Management System (LMS), Quality Management Systems (eQMS), and to implement process improvements to meet business and regulatory requirements. This position will report to the Associate Director, Quality Systems.
Qualifications
- Bachelor’s degree in computer science, Life Science or related field
- 4+ years in Quality Systems/Quality Assurance experience in the life sciences industry.
- Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
- Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience
- Participate in system validation activities, as required
- Experience developing improvements to electronic Quality Systems.
- Experience with Dot Compliance, preferred.
Responsibilities
- Supports the day-to-day management of the Quality Systems department, including areas such as Document Control and Training.
- Assist with the development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.
- Maintain internal formatting standards and ensure all documentation is formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements.
- Assist with the Quality training program including collaborating with department managers to develop training requirements and training plans.
- Create and maintain GxP training files and matrices.
- Generate compliance metrics and prepare routine KPI reports.
- Assists in delivery, maintenance, and continuous improvement of GxP processes in eDMS, eLMS, and eQMS.
- Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
- Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
- Strong software proficiency with Microsoft Suite and other desktop applications.
- Ability to manage multiple projects in a dynamic environment with attention to detail.
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
- Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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