Senior Documentation Associate, Quality Assurance - Innovative Gene Therapies
Reporting To: Manager, Document Control
Location: Menlo Park
Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.
The Senior Associate, Quality Assurance will be responsible for supporting the documentation activities in support of vector and drug product production and release. This position has interactions with various functional areas such as Cell Therapy Operations, Vector Manufacturing, Analytical Operations and Regulatory Affairs. The person in this role is essential and will ensure the efficient routing, approval, issuance, tracking and training on documentation.
- Ensures support with compliance and ongoing preparation for new projects
- Knowledge of vendor qualification and management
- Assist with internal training on QA Policies and Procedures
- Maintains equipment history files
- Establishes and maintains personnel training records and ensures training is current
- Assist in the generation and review of documents used in Manufacturing and Quality Control Testing for accuracy and completeness
- Prepares documentation for filing and maintains original documents and computerized files to support all documentation systems
- Ensures that records are secure, and retrievable throughout defined record retention periods
- Assigns deviation report numbers and maintain all approved reports
The ideal candidate should have:
- Ability to work independently and in a group on a variety of projects
- Ability to maintain a high degree of accuracy and attention to detail
- Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively
- Capable of assisting with analysis of trends and metrics that lead to improvement
- Must be able to multi-task and establish priorities
- Must work well with others and possess effective teaching abilities
- A thorough knowledge and understanding of Canadian, US FDA and European regulations (GMP), as well as experience with GLPs.
- Competency with electronic Quality Management Systems
- Proficiency in Microsoft Office (Word, Excel, Outlook, etc.)
- Excellent verbal and written communication skills required
- Strong presentation and negotiation skills required
EDUCATION & SKILL REQUIREMENTS:
- A Bachelor’s in Chemistry, Biochemistry, Biology, Pharmacy, or in a related discipline
- A minimum of three (3) years knowledge and working experience with all aspects of quality assurance, which relate to a pharmaceutical development organization
- Planning, organization and execution skills
- Strong problem-solving techniques and ability to make sound decisions
- Direct and relevant experience with biologics or biotechnology derived products
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
Notice to RECRUITERS: All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.