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. Qualifications • High School/GED is required. Technical school completion/certification preferred. • 6+ years of overall experience in Manufacturing, Quality or Engineering • Good verbal and written communication skills. • Good problem solving and analytical skills. • Good interpersonal relations / communications skills. • Good negotiation skills. • Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. • This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.