Purpose:
The Senior Support Specialist plans and executes validation activities, processes shopping carts and requisitions in SRM/ECC to ensure timely delivery of the goods and services required to support the business. Under the direction of the Laboratory Operations Support Lead, this role supports implementation of the QC Laboratories’ validation program. Key responsibilities include auditing commissioning and validation documentation; leading and documenting investigations; implementing corrective and preventive actions; drafting and reviewing QC Laboratory standard operating procedures; reviewing and approving critical planned maintenance routines; preparing laboratory samples for qualification; supporting the establishment of plant quality systems; creating RCEs; and managing purchasing activities.

Responsibilities

• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System.

• Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.

• Executes tasks as assigned to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.

• Maintains a change control program for the validated/qualified systems to assure their capability of continuing to meet quality requirements.

• Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.

• Ensure completion of validation activities within the allowed time and cost.

• Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.

• Manage and process the SRM shopping cart / ECC requisition queue to ensure timely processing of POs.

• Ensure shopping carts, requisitions, and POs include the required documentation, correct category code, and are compliant with purchasing policies and procedures.

• Participate in invoice resolution regarding changing purchase orders as needed.