Manufacturing Operations Specialist

Key Responsibilities:

• Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance.
• Ensure Manufacturing Support areas are maintained in an “audit ready” state.
• Ensure equipment cleaning and maintenance is performed per governing SOP requirements.
• Escalate any observed compliance or safety issues and support reconciliation of event.
• Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc.
• Support monthly and annual cycle count and support all site/team projects and initiatives.
• Coordination of receiving, storage and processing of materials and ensure proper status segregation and storage of all conditioned and ambient materials.
• Ensure inventory accuracy of GMP and non-GMP LN2 storage locations
• Ensure accurate SAP/MES inventories are maintained for all components.
• Ensure Kanban system is accurate and materials are consumed per FEFO/FIFO.
• Ensure kitting/staging of initial kits are complete for each shift and timely response to kitting requests for production and monitor staged kits for expired materials and to ensure utilization prior to expiry.
• Ensure all gowning materials in the ISO8 staging area are maintained to adequate levels and ensure dispensary area has ample supply of non-BOM items.

Essential Requirements:

• High School Degree or GED equivalent; Bachelor’s degree preferred
• At least 1 year of related experience in cGMP/FDA regulated industry required
• SAP knowledge preferred 
• Must be well organized, flexible and work with minimal supervision.
• Ability to lift up to 50 lbs.
• Alternate shifts, weekends and overtime will be required
• Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials

The pay range for this position at commencement of employment is expected to be bbetween $28.79 and $43.22 per hour ; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.