Manufacturing Suite Coordinator

We are seeking a motivated individual capable of facilitating manufacturing processes following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment. Reporting to the 1st shift manufacturing manager but collaborating with all 3 shifts and the supply chain. The Suite Coordinator position will require interaction with manufacturing personnel and leadership, manufacturing technical managers, Quality assurance, Quality control and the supply chain to facilitate the delivery of the production schedule for a biologic vaccine product. The individual will be expected to demonstrate expertise and breadth of knowledge in logistics, manufacturing operations with raw materials and single use components and considerable operational knowledge of SAP.

Duties/ Responsibilities:

The Manufacturing Suite Coordinator is required to:

• Safety mindset - Works cross functionally to eliminate existing and potential safety hazards.
• The position requires a Quality mindset and demonstrated proficiency with Good Documentation Practices, cGMP manufacturing, and cleanroom behaviors.
• Responsible for the ordering, delivery and inventory management of raw materials, chemicals, WFI, product intermediates and single use components to achieve the manufacturing schedule (may be applicable to commercial scale product, development studies, clinical scale production or validation activities).
  • Strong knowledge and understanding of manufacturing process, manufacturing steps and buffer preparation as it pertains the materials and components required to perform manufacturing.
  • Strong knowledge of SAP; Material transactions, inquiries and TECO resolution.
  • Manage manufacturing component needs collaborating with manufacturing and supply chain to order, receive, wipe down and distribute chemicals, WFI, single use components and Kanban supplies into production area to assure manufacturing execution to schedule.
  • Manage non-BOM, Kanban, chemical and WFI supplies; define manufacturing area stock levels, frequency of replenishment, perform periodic in-suite expiry check (label verification) and remove expired materials.
  • Production in-suite inventory management (including cold chain): periodic cycle counts, spot checks as requested, returns and expiry management.
  • Responsible for maintaining the visual management board for materials deliveries and movements within the manufacturing space.
  • Read and execute detailed written procedures and production records. Able to author and revise technical procedures and forms.
  • Pushing buffer containers ranging from 50L to 200L.
  • Ability to remain on your feet for up to 2 to 3 hours, gowned in a cleanroom for an 8hr shift (with breaks), wear PPE or sitting for periods of 2 to 3 hours.
• Lead Root Cause Analysis (RCA), participates in DMAIC and Leads continuous Improvement Teams (such as 5S, Gemba, etc.).
• Manufacturing is performed is on-site, 5 days a week, the manufacturing schedule may require work on holidays. Occasional overtime support is required on weekdays or weekends.

Team Working (Ways of Working):

The Manufacturing Suite Coordinator must work effectively with the manufacturing team members across shifts and with manufacturing support teams and regularly performs the following team working skills:

• Training:
  • Demonstrate procedures for learning or as a part of training sessions for other team members.
  • Oversee training for new employees on material movements physically and in SAP.
  • Provide knowledge of manufacturing materials movement, stocking, inventory, and SAP execution/ TECO for improving the training process, curriculum and improving the on boarding of new employees.
• Schedule Execution:
  • Must be aware of the activities, processes, and procedures to meet the schedule and deliver with quality, Right the first time.
  • Will provide the schedule for material movements schedule for supply chain and manufacturing (BOM, Chemicals, and WFI) to obtain the manufacturing schedule.
• Multi-department collaboration
  • Collaborate effectively with external stake holders (QA, QC, SC, auditors, global colleagues, etc.) to convey accurate process related information.
  • Makes recommendations to improve work processes and implements changes to BOM's to assure that manufacturing receives the right materials for process execution without excess parts.
  • Supports supply chain with effective inventory management and reporting.
  • Work with support teams on all necessary event investigations, material movements (SAP) and inventory system cycle counts and discrepancies (TECO).
• Lead team meetings and facilitate multi-department discussions as assigned.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• HS Diploma or GED with 3+ years of experience in GMP manufacturing or manufacturing support
• OR Bachelor's degree with 2+ years of experience in cGMP manufacturing
• MS Word and Excel experience
• Experience with SAP Enterprise Resource Planning application
• Ability to lift up to 25 lbs

Preferred Qualifications:

• Experience with SAP transaction codes around material movements for the manufacturing process; Process Orders (PO), Transfer Orders (TO), Component Checks (CC), and the reconciliation of materials in SAP - Technically Complete (TECO)
• Experience in cGMP manufacturing around managing materials movements - ordering, stocking, wiping down, inventory, cycle counts, expiry management and returns to warehouse
• Experience with single use technology and aseptic connections and assembly of single use processes components for cGMP manufacturing
• Adaptable to change and collaborating well with key stakeholders in a cross functional environment with Supply Chain, QA, MSAT and Process Engineering
• Self-motivated, takes initiative and drives for the implementation of solutions and improvements
• Involved in investigating process deviations and implementing corrective and preventative actions
• Bachelor's Degree
• Supply chain logistics experience
• Good verbal and written skills, ability to write legibly and grammatically correct

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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