Senior Quality Specialist
Seer is seeking a Senior Quality Specialist, who will concentrate on establishing and overseeing the company’s Document Management System while supporting the development, implementation and maintenance of the Clinical Laboratory’s Quality Management System (QMS). The ideal candidate will have significant relevant experience and a track record of accomplishments in the life sciences/biotechnology industry. This role is part of the Quality Assurance team focused on ensuring quality system compliance throughout the organization. This role requires strong interpersonal and team oriented skills.
The successful candidate is expected to have a minimum of five years of relevant Quality Assurance experience, including at least two years in documentation management, in a regulated life sciences environment.
This role will be based in the South San Francisco office through late 2019. Please note, the company is moving to its permanent location in Redwood City at the end of the year.
Areas of specific responsibility and attention will include the following:
- Lead and support development, implementation and maintenance of the QMS and activities such as document control, training, non-conformances, deviations, CAPAs, audits and process monitoring
- Establish and serve as Administrator for company’s Electronic Document Management System (EDMS) for processing and managing document changes, workflow development, user account maintenance, data backup, etc.
- Collaborate and assist cross functional team members to ensure completeness and accuracy of submitted changes and timely release of controlled documents
- Maintain quality system related document/record retention including databases and logs (e.g. training records, laboratory notebooks, off-site records archival storage/logs, regulatory standards, etc.)
- Collaborate with supervisors/managers in defining and managing employee training requirements
- Develop and provide QMS performance metrics in support of management reviews
- Provide training, guidance, and support to the company for QMS related policies and procedures
- Support audits conducted by internal auditors and external regulatory agencies as needed
- Other duties as required
The successful candidate for the position of Senior Quality Specialist must have a demonstrated record of accomplishments in the life sciences industry. The ideal candidate will have had significant experience working in regulated clinical labs/biotech start-up/fast growth company or similar working environment.
Candidates must bring a strong entrepreneurial orientation along with teamwork skills and an absolute commitment to competing with the highest level of integrity.
Key requirements include:
- Bachelor’s degree preferred
- At least five years experience in a regulated clinical laboratory or life sciences environment
- Possess a solid understanding of document standards, criteria and conventions
- Excellent analytical and problem-solving skills
- Working knowledge of quality management systems and related regulations (CLIA, CAP, CA State, NY State)
- Proficiency with Electronic Document Management Systems preferred, including experience with MediaLab
- Strong written, oral and listening communication skills, with demonstrated experience in cross-functional and timely communication
- Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Seer’s scientific and business goals
- Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment
- Highly organized, exceptional attention to detail, and strong proficiency in documentation skills
- Proficiency working with Microsoft Office applications
Bachelor’s degree is preferred. Specific title and responsibilities are flexible to match a given candidate’s experience.