Specialist I, QA Software Administrator

 

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I.    JOB SUMMARY 

The Specialist I role will be responsible for activities related to the lifecycle of equipment, systems, and facilities.  This includes the execution and documentation review and approvals of projects, validation, calibration, and facilities activities to ensure that all cGXP instruments, equipment and systems are maintained in a calibrated and validated state.  The position requires understanding of data integrity and 21 CFR Part 11 requirements. Role requires working with cross functional teams to identify computerized needs for new systems, upgrading systems and decommissioning to ensure proper equipment is used and compliant. The individual will provide support to ensure change management, CAPA, deviations, training, Good Documentation practices, SOP and IT systems reviews are conducted in accordance with established policies and procedures. The position requires strong technical knowledge of computerized laboratory and enterprise systems, GAMP processes, and risk management.

 

II.    ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Provides technical quality review and approval of documents, qualification documents related to Quality Systems.
•    Review and approval of calibrations and other facilities and equipment related documents to support Quality Systems.
•    Represents Quality in key decision-making regarding requirements for CAPEX and validation projects. 
•    Reviews and approves validation, technical documents, facilities, and maintenance documents i.e., work orders, calibrations, preventive maintenance. 
•    Manages the site change control program regarding new product introduction, equipment, and facilities. 
•    Has a broad expertise or unique knowledge, uses skills to contribute to development of company objectives. Achieves goals in creative and effective ways. 
•    Serves as change agent for continuous improvement within the scope of work. 
•    Frequently interacts with direct manager and other cross functional peers to gain alignment on sound quality decisions. 
•    Provide support during regulatory and internal inspection activities as needed. 
•    Coordinate/lead cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding.
•    Must work independently and manage time.
•    Must be detail oriented and conduct thorough reviews and approve documents on behalf of Quality Systems.
•    Review and approve other documents as needed.
•    Support and partner GMP departments across the site.

 

The above statements are intended to describe the nature of the work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Education: 
•    Bachelor’s degree in science or engineering from an accredited university or college
•    A minimum of seven (7) or more years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment in calibration, validation, operations, engineering, or any combination thereof 
Experience:
•    Experience with investigations into deviations and determination of impact, root cause, and corrective actions 
•    Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, CIP skids, autoclaves, parts washers, HVAC systems, building chillers, clean steam generators, WFI generation, storage, and distribution, RODI water system, and Temperature Controlled Units (e.g., refrigerators, freezers, and incubators) is an advantage. 
•    Demonstrated success in independent judgment, technical proficiency, and collaboration with others in a cGMP environment. 
•    Must be a team player and able to work cross-functionally in a matrixed environment. 
•    Must have excellent written and verbal communications skills. 
•    Excellent organizational and interpersonal skills. 
•    Ability to work as part of a high performing team and collaborate effectively with staff at all levels, and across all functions. 
•    Demonstrated ability to manage multiple activities while maintaining a high level of organization. 
•    Demonstrates initiative; ability to undertake ad