Senior Specialist, Quality Control Informatics

 

Title – Senior Specialist, Quality Control  Informatics

Location: Phoenix, Arizona, United States

 

POSITION SUMMARY

Independently plan, lead and execute the implementation and ongoing support of laboratory software/systems. Collaborate with system users and local as well as corporate IT support to identify and implement systems which support the company’s needs. Ensure realization through the development of value added enhancements while conforming to the system development life cycle. The incumbent assures individual compliance with global regulatory requirements, cGMP’s and applicable department programs, including training, documentation, standard operating procedures, and the company’s policies and procedures.

 

ESSENTIAL FUNCTIONS

• Serve as Lead Systems Administrator to manage system restoration, data migration, upgrades and training for scientific applications.

• Meet established goals and practices by employing basic project management concepts.

• Identify problems, determine root cause and develop solutions independently or as part of a team and coordinate with management for implementation of solutions.

• Translate user requirements and configure system solutions designed to meet IT guidelines and customer needs.

• Implement and test changes to computerized systems: configure systems, build templates, create & design reports and forms, create methods, and transfer templates to production environments.

• Evaluate impact of potential changes to the laboratory systems & related applications.

• Apply advanced knowledge of laboratory software applications to troubleshoot, problem solve and propose system improvements.

• Understand emerging technology, propose new system solutions/upgrades to improve laboratory applications and evaluate potential impact and risk relating to the business.

• Develop, review, and revise associated departmental SOPs, design/configuration specifications, and training documents; ensure accuracy, completeness, and compliance with cGMPs and FDA regulations.

• Interact with outside contractors and vendors to justify, budget and purchase new software and computerized systems.

• Plan, coordinate and participate in validation processes, including protocol and report generation and review; ensure compliance to

21 CFR Part-11 requirements.

• Maintain the validated state of the laboratory software/systems.

• Assist laboratory personnel with computer software application issues and perform training/qualification of laboratory personnel.

 

EDUCATION/EXPERIENCE REQUIREMENTS

• Requires a Bachelors degree in Science, Computer Science or related field from an accredited college or university and a minimum of Six (6) years related computer network administration experience in a regulated laboratory, preferably a pharmaceutical environment. An equivalent combination of training and experience may substitute.

• Knowledge of Current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), Food and Drug Administration (FDA), and other regulatory requirements.

• Demonstrated strong trouble shooting skills.

• Proficient in the use of business, scientific and personal computer software and hardware, system security data collection hardware, operating systems and application software.

• Strong written and oral communication skills.

 

Computer/Software Skills

Requires proficiency in basic MS Word, Outlook, Excel

Compliance Knowledge

Requires ability to deal appropriately with regulatory agencies

Requires general knowledge of cGMP, OSHA, DEA, USP and EP

Requires detailed knowledge of cGMP, OSHA, DEA, USP and EP

General Competencies

Requires flexibility and ability to multi-task

Requires strong written and verbal communication skills

Requires strong organizational and time management skills

Requires strong critical reasoning and decision making skills

Requires strategic thinking and ability to work independently

Written Communication

Requires ability to interpret / write general business documents

Requires ability to interpret / write technical documents

Training Skills

Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance

Requires strong presentation development and delivery skills

Problem Solving

Requires ability to solve routine and complex problems

Level of Supervision

Requires direct supervision

Impact of decisions

Impacts one department

 

Requires uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment

Requires pre-employment screening (full physical, partial physical, lift test, etc…)

Requires safety alertness due to work around hazardous equipment and conditions

Requires personnel monitoring due to handling of hazardous substances