KNOWLEDGE AND SKILL REQUIREMENTS:
- Working knowledge of cGMP, ISO 13485, ISO 27000, ITIL, GAMP quality system requirements relating to computer systems and electronic data
- Strong management and training skills
- Detail oriented and organizational skills
- As process owner, key implementer of the Quality Plan, ensures that the metric reporting requirements are met in timing and quality.
- Good customer service skills.
- Reliable, with high integrity and strong work ethic.
- Ability to work as part of a team.
- Professional appearance and attitude.
- Ability to keep a positive attitude in a fast-paced environment.
- Ability to effectively communicate, both verbally and in writing, with tact and diplomacy.
- Ability to maintain confidentiality.
- Ability to manage conflicting priorities and customer expectations.
- Ability to use good judgment, initiative and be accountable in making decisions in accordance with established guidelines.
- Effective analytical skills and problem-solving capability.
- Strong time management skills, with ability to manage workload efficiently, including planning, organizing and providing status on a variety of tasks, assignments, projects and reports.
- Effective team building and motivational skills.
- Demonstrated ability to work effectively in a diverse workforce.
- Ability and willingness to work various shifts, holidays, be on-call and travel as necessary.
- Thorough understanding of local area and wide area networking protocols
- Knowledge of Cybersecurity principles and technologies
- Knowledge of Cloud platforms (AWS, Azure, Google Cloud)
- Knowledge of Database management (SQL, Oracle, PostgreSQL)
- Knowledge of Microsoft/Office 365
- Knowledge of Active Directory and Group Policies
- Knowledge of modern Microsoft operating systems
- Knowledge of ITIL or service management frameworks
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in Information Technology an equivalent combination of experience and/or education required.
- 5+ years of experience in Information Technology management
- Two or more years of work experience in an FDA and/or ISO regulated environment preferred.
GENERAL COMPETENCIES:
- Adapts to change, open to new ideas and responsibilities.
- Communicates well (written and verbal), delivers presentations, has good listening skills.
- Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically with utilizing MS Office; word documents, spreadsheets and create a slide presentation (Power Point). The level of proficiency is defined by the requirements of the position held.
- Good listener, committed to finding solutions to problems, works well with difficult people.
- Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers.
- Able to reach fact-based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions.
- Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record.
- Honest, accountable, maintains confidentiality.
- Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit and/or the organization; provides individuals information so that they can make accurate decisions; is timely with the information. Effectively communicates up and down the chain of command.
- Takes action, seeks new opportunities, and strives to see projects to completion within the job description boundaries.
- Creative, offers new ideas, risk taker, amenable to change.
- Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback.
- Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks.
- Strives to understand contributing factors, works to resolve complex situations.
- Manages workload, works efficiently, and meets goals and objectives.
- Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complies with quality system requirements.
- Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement.
- Looks for opportunities to increase knowledge, works to increase responsibility, and strives to achieve personal goals.
- Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner.
- Accountable to team, works to meet established deliverables, appreciates view of team members, respectful.
- Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity.
PHYSICAL REQUIREMENTS:
Frequently sit and stand, occasionally walk. Frequently use hands to finger, handle, or feel. Frequently reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch, or crawl. Constantly talk or listen. Occasionally Lift 1-25lbs. 1-33% of the time. Carry 1-35 lbs. 1-33% of the time. Frequently work near moving mechanical parts. Occasionally work in high places, occasionally exposed to fumes or airborne particles, occasionally exposed to toxic or caustic chemicals. Moderate noise level is typical for the work environment of this job.
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