The Quality Assurance Document Control Associate will assist with the management, organization, and maintenance of all quality-related documentation within the organization. This role ensures that all documents meet regulatory standards and are easily accessible for audits and reviews. The candidate will work closely with various departments to ensure that documentation practices comply with internal and external quality standards. The candidate will have a strong attention to detail, excellent organizational skills, and an understanding of quality assurance principles. Experience with Electronic Document Management Systems (EDMS), such as Veeva Quality Vault, is preferred but not required. To be considered for this position, you must have a BS/BA degree in life sciences or a related field and have 0-5 years of experience in Document Control. This position reports into the Senior Manager, Document Control & Training Position Responsibilities:
- Maintain all documents related to the manufacturing processes, including but not limited to executed batch records and Certificates of Analysis, within the EDMS
- Create batches within the electronic Quality Management System (QMS) and track and upload documents required for batch disposition
- Upload external documents to the EDMS for archival
- Follow policies, SOPs, and work instructions to support the document change control process, assign effective dates and training workflows, and archive documents
- Individual may assist in developing, managing, and maintaining Madrigal Standard Operating Procedures (SOPs), work instructions, protocols, and policies
- Participate in periodic reviews of documents within the electronic document system to ensure formatting complies with current templates
- Manage document lifecycle, including creation, revision, approval, distribution, and archiving
- Assist with the creation of document control metrics, reports and dashboards
- Work in preparing and organizing documentation for internal and external audits
- Assist users with document related activities in the EDMS
- Assist departments with offsite archival of documents and maintain full traceability
- Maintain confidentiality and security of all documents and information
- Communicate effectively with team members and management to provide updates on document control activities
- Manages internal quality improvement initiatives: evaluate internal processes, and suggest/design/implement improvements
- Provides clerical and administrative support related to documentation processes and systems to include reviewing for conformance to document templates and format
- Pre-approves and routes documents for review and approval in Veeva QualityDocs.
- Responsible for filing and maintenance of GxP controlled documents and records. Ensures files are accurate and easily retrievable
- Provides additional support and assistance on tasks and projects as directed by management
- Operates as an effective liaison to internal corporate cross-functional areas, CMC/QA consultants, and external partners/contractors
- Participate in quality improvement initiatives and projects
- Stay updated on industry best practices and regulatory changes related to quality assurance documentation and maintain required knowledge of applicable regulations, guidelines, and company standards and procedures
Qualifications and Skills Required: - BS/BA, with 0-5 years' experience, preferably in pharmaceutical and/or biotech environment in document control and management
- Experience with Veeva specifically Quality Docs, Training and QMS modules
- Proficiency in MS Word, Excel, Power Point, and DocuSign Part 11
- Candidate will have knowledge of GXPs, especially Good Documentation Practices and a good understanding of GMPs
- Excellent organizational and time management skills
- Strong attention to detail and accuracy
- Effective communication and interpersonal skills
- Knowledge and experience in development, and/or reviews of policies and procedures (i.e., policy documents and SOPs)
- Knowledge of FDA regulations and ICH Guidelines in the pharmaceutical and/or biotech manufacturing environment
Working Conditions: - Office environment (partially remote)
Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.