At Heron, our mission is to improve the lives of patients by developing best-in-class medicines that address unmet medical needs. We are developing novel, patient-focused solutions that apply our innovative science and technologies to already-approved pharmacological agents.
If you are looking for a career in a company that's evolving, has a great culture and amazing opportunities within the Biotech Industry, Heron is the clear choice. As part of the Heron team, you will work with motivated team members who have pride in - and passion for - what they do. Guided by our core values, we remain steadfast to our commitment to career growth and development for all levels of team members.
We are looking to add the position of EDMS Document Control Systems Specialist II to our collaborative and entrepreneurial team who share our passion for helping patients.
The EDMS Document Control Systems Specialist II is responsible for building, implementation, training, and routine operations of the EDMS system, Master Control. The person is responsible for ensuring all paper documents are filed properly and transferred to the EDMS system as appropriate.
What You'll Do:
• Organize and ensure accurate and reliable filing systems for all paper-based GMP documents.
• Ensures all training is complete by all GXP personnel and up to date in the EDMS system.
• SME in managing and transferring paper based system to EDMS system document solutions for the organization (Master Control).
• Provides timely documentation for the organization and contract customers.
• Responsible for CGMP for maintenance of accurate and complete QMS records, standard operating procedures and other controlled documentation.
• Must clearly and frequently articulate and influence the “quality position” at the site.
• Input data for tracking quality metrics as required.
• Provide Communication on the document control system with direct manager, on a routine basis.
• Trains end users on EDMS/LMS Document Control Management application as needed.
• Responsible for assisting in PAI and other inspection readiness.
• Supports the development and management of quality metrics to optimize performance, productivity, and effective resource planning.
• Responsible for off-site document archival and destruction per company policies.
• Participates in cross-functional project teams.
• Assist in Due Diligence activities.
• Bachelor's degree in a life science preferred with a minimum 5+ years of experience in a GXP document control position, and 5+ years of experience in archiving, inventory, maintaining and creating paper based systems and EDMS.
• Strong experience with Document Management in Master Control. Implementation and deployment of Master Control systems is highly desirable.
• Strong Document Control experience in support of FDA submissions/inspections. New Drug Application (NDA) is highly desirable.
• Excellent communication skills, with strong organizational, planning and follow-through, and computer skills. Ability to prioritize and multi-task independently.
• Ability to think analytically and attention to detail, exercise judgment within generally defined practices and policies in selecting methods and techniques to resolve complex problems positively and professionally.
• Demonstrated leadership skills and ability to interact with all levels of management in a multi-disciplinary team environment.
• Knowledge and understanding of ICH, CGMPS for Pharmaceuticals and Devices and relevant regulatory requirements.
• Quality-service attitude and willingness to work additional hours to meet deadlines.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all-inclusive or limit the duties of the position.
The Heron team works in a fast-paced, challenging, and rewarding environment, while enjoying regularly scheduled corporate events, a casual and flexible atmosphere, and excellent benefits, which include:
• Competitive Compensation with Bonus Potential
• Full Health Benefits - Medical/Dental/Vision
• 401k, Flexible Spending, Employee Stock Purchase Plan
• Paid Time Off, Sick Pay and Tuition Reimbursement
As an equal opportunity employer, Heron Therapeutics, Inc., is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Heron Therapeutics, Inc. career website as a result of your disability. You may request reasonable accommodations by calling 858-251-4400.