The GMP Warehouse Lead will:
Lead daily warehousing operations including staging, cycle count, receiving, storage, quarantine, and release of materials per SOP are compliantly executed
Work closely with Supply Planners, Shipping and Receiving, Facilities and Quality Assurance teams to ensure uninterrupted manufacturing operations
- Ensure receipt and facilitate release of GMP materials by warehouse team; communicate with support and customer groups (internal and external) to ensure GMP warehouse functions are being performed in a timely and accurate manner.
- Lead and develop GMP warehouse team members.
- Lead/Support ERP system improvements and upgrades related to warehouse operations
- Initiate and update GMP Warehouse documentation, such as SOPs, Change Controls and Quality Investigations
- Track JIT inventory
% of Time
Job Function and Description
Ensure receipt and facilitate release of GMP materials by warehouse team; communicate with support and customer groups (internal and external) to ensure GMP warehouse functions are being performed in a timely and accurate manner. Lead and develop team members.
Perform material receipt, quarantine, and release in accordance with QA procedures; perform rejection and disposal/destruction as appropriate. Lead/Support operation improvement projects and performance monitoring.
Initiate and update GMP Warehouse documentation, such as SOPs, Change Controls and Quality Investigations; Document/record and review GMP data and information; Review GMP documentation for accuracy, quality and compliance.
Lead cycle counts, investigate discrepancies and implement corrective measures;
Remain knowledgeable and comply with all HAZMAT regulations.
Education and Experience Requirements
- Minimum 7 years experience in Biopharmaceutical / Cell and Gene Therapy industry
- Five (5) years experience in a Warehouse Management / Supervisory role preferred
- cGMP environment experience required
- Biopharmaceutical/Cell and Gene Therapy experience preferred
- Ability to excel in a regulated environment
- Lean experience strongly preferred
Key Skills, Abilities, and Competencies
- Demonstrated understanding of GMP Warehouse, inventory control and cGMPs
- Expertise in GMP warehouse operations
- Experience in leading and developing teams
- Strong communication and collaborations skills
- Experience with warehouse applications (i.e. Oracle and/or SAP, MRP/ASCP, etc.)
- General knowledge of other operational areas such as Manufacturing, QC, QA, Materials Planning, etc.
Complexity and Problem Solving
- Develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships internally and externally.
- Works under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
- Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
Internal and External Contacts
- Frequent internal company and external contacts. Represents organization on specific projects
Other Job Requirements
- This position requires physical demands of lifting up to 55 pounds and may involve work with hazardous materials.
- The position may require occasional extended shift work, including weekends, off hours and holidays as needed.
- May require up to 10% domestic and international travel.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.Learn more about Spark Therapeutics and view other openings.