Document Control Specialist
Role: Document Control Specialist
Reporting to: Director, Quality Assurance and Quality Control
Location: San Francisco, SOMA
Status: Part-time consultant, up to 24 hours/week (may consider FT position for exceptional candidates)
PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. The U.S. Food and Drug Administration awarded a Breakthrough Therapy Designation and Orphan Drug Designation to Patidegib after presenting positive Phase II data evaluating the safety and efficacy of the therapy in patients with Gorlin Syndrome. PellePharm is aiming to initiate the Phase III trials of the topical hedgehog inhibitor in 2019. PellePharm recently announced a partnership with Leo Pharma, a Dutch pharmaceutical company, which enables the company to execute the Phase III studies, and marks Leo Pharma’s entrance in rare skin disease.
The Document Control Specialist, QA/QC will provide support to the Quality Assurance (QA)/Quality Control (QC) and Chemistry and Manufacturing Controls (CMC) departments by assisting in the execution of GXP quality activities, including but not limited to: creation and processing of document change control documentation, management of standard operating procedures (SOPs), GXP record processing and archival, offsite record storage, employee training, support of deviation and CAPA programs, support of vendor files, and generation of quality metric reports. This role will report to Director, QA and QC and will work closely with Clinical Operations, CMC, Nonclinical, service providers, and vendors.
The Document Control Specialist, QA is expected to perform the following functions:
- Create and process document change control documentation
- Maintain paper and electronic SOP and GXP documentation systems
- Maintain document trackers and indexes for GXP activities; Quality and CMC
- Develop, update, manage, and maintain company SOPs in close cooperation with functional area representatives
- Process and archive GXP records
- Administer SOP training
- Setup and maintain GXP employee training records
- Prepare and distribute quality metric reports
- Assist in investigation of deviation and CAPA activities
- Provide general support for the overall Quality System
- Prepare documents for offsite storage
2+ years in document or records management in a pharmaceutical cGXP environment
- Proficient with computer (MS Office) and internet skills
- Experience of working with many file types
- High school diploma is a must, Bachelor degree will be preferred
- Highly organized with attention to detail
- Ability to manage multiple tasks with excellent record-keeping skills
- Excellent written and verbal communication skills
- Excellent collaborative skills
- Can do attitude
Compensation will depend on employment status. PellePharm offers competitive rates to employees and consultants. Other than working with a great team of smart, passionate and energetic people, Pellepharm also offers to its employees a competitive salary and benefits package that includes 100% coverage of health care premium, life insurance, 401k and perks.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.
PellePharm is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need.
IF YOU ARE INTERESTED IN THIS ROLE, PLEASE SEND YOUR CV