Operational Quality Systems Specialist I

 FLSA Classification: Non-Exempt / Hourly  

Position Summary/objective: 

This position will provide support to the Operational Quality Systems team by guidance and oversight on tasks related to training and document control.  

Essential functions: 

• Responsible for maintaining the existing quality system while ensuring compliance with applicable policies, procedures, and regulatory requirements.  

• Instrumental in improving the quality system as applicable.  

• May lead quality system projects, audit readiness activities, improvements or initiatives and collaborate with site operations and engineering teams. 

• Monitor and review Quality Management Systems (Quality Systems, Audits, CAPA, Complaints, Document Control, Training, Metrics) and Batch Record Issuance procedures to ensure and maintain compliance with corporate and regulatory agency requirements 

• Contribute to the writing, coordination, review, approval and maintenance of the OQS Procedures and documents. 

• Coordinate, support, and investigate Corrective and Preventive Actions (CAPAs).  

• Perform quality metrics/key performance indicators (KPIs) to track compliance performance and analyze data to implement improvements and streamline processes and procedures.  

• Maintain and manage DMS, employee training items until their closure.  

• Assist in Change Control process from initiation, revision of documents and processes up to training and implementation.  

• Assist in preparing OQS Ops training materials and perform training as required.  

• Support cross-functional groups for OQS Ops functions and projects 

Secondary functions: 

• Ability to make sound decisions and approach problems with curiosity and open-mindedness 

• High degree of independent working, analytical reasoning, and the ability to communicate effectively.  

• Careful editing and documenting of results.  

• Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by constant striving for excellence.  

• Dedication to innovation and science.  

• Ability to approach tasks in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skills. 

Competencies: 

• Excellent verbal and written skills 

• Works independently 

• Strong communicator and collaborates effectively  

• Strong attention to detail 

• Flexible and able to work under pressure and meet project timelines 

• Proficient with MS Office applications 

Work environment:  

This is a sedentary position (at least 85% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected.    

Physical demands:  

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.   

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.   

• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, touch screens and others.    

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.   

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).    

• Pushing - Exerting force upon an object so that the object moves away from the object.   

• Pulling - Exerting force upon an object so that the object moves toward the force.    

• Sitting – remaining in a sitting position for at least 85% of the time.   

• Standing/Walking - remain on one's feet in an upright position at a workstation.    

• Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.   

Required education and experience: 

• Bachelor’s Degree. (Science preferred)  

• A minimum of 1 to 2 years working in a fast-paced environment with minimum supervision. (Biotechnology preferred)