Job details
Salary from $65,000 a year job type full-time number of hires for this role 1
Full job description
Change control specialist
Make a difference at an industry-leading company that is saving livesAt secure transfusion services (“sts”), we work with the nation’s top hospitals to improve how they access blood components, enabling the delivery of lifesaving careThe ceo and leadership team are dedicated to making sts a great place to work and our growing company offers a positive, diverse, and supportive culture; a stock package for all employees; competitive compensation and benefits; and the opportunity for meaningful career growth and developmentWe value people who bring enthusiasm and creativity to their work combined with humility and curiosity to always be learningThis is an opportunity to engage with individuals who are united by a strong sense of teamwork and share a passion for helping others.
Under the direction of the vice president of regulatory and quality, the change control specialist assists in all aspects of process and project development, including change and risk assessment to facilitate effective and compliant changeThe change control specialist will work closely with the members in the document and change control and all company departments in harmony to facilitate the goals and objectives of organization.
Read on to learn more about the role and visit www.securetransfusion.com to learn about our innovative approach to revolutionizing the us blood systemIf you are as excited as we are about being part of change, reach outWe can’t wait to meet you.
Responsibilities:
Contribute to organizational mission via professionalism in customer service interactions and accuracy of workThe employee must be courteous, conscientious, and professional when dealing with both internal and external customersPromotes teamwork and communication.
Manages all aspects of assigned projects, including, but not limited to, interdepartmental personnel, timelines, and daily schedules.
Maintains files of the execution of assigned change requests.
Coordinates change and process activities through constant communication with affected departments and personnel; oversees and reviews processes and procedures.
Identifies, reviews and refines requirements and determines the scope of testing required for changes.
Develops ways to verify process requirements.
Assist in the development of procedures and controlled documents according to set standards regarding order, clarity, conciseness, style and terminology in compliance with fda regulations and industry standards for collection and manufacturing facilities and corporate departments.
Participates in the execution of validation protocols.
Implements and drives continuous improvement activities utilizing the change management process and incorporation of regulatory best practices.
Interacts internally with operational, information technology, laboratory, change and document control, quality assurance and regulatory affairs personnel.
Interacts externally with regulatory and external audit teams
Performs all other duties as required/assigned.
Required education, skills & experience:
Bachelor of science in business administration or biological sciences, preferred.
Familiarity with blood establishment computer systems (becs), preferred
Must have good interpersonal and communication skills.
Excellent attention to detail.
Excellent organization and follow-up skills.
Excellent problem-solving skills and ability to analyze situations in a timely manner.
Ability to organize, work and prioritize assignments in a fast-paced multi-functional team environment.
Establish and maintain effective working relationships within the sts network and provide excellent customer service.
Proficiency with computers.
Ability to travel 10% of the time
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Physical requirements: required to regularly stand, use hands, reach with arm, and talk and hearFrequently required to sit, stoop, crouch, kneelMust frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 poundsVision abilities required include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Environmental requirements: possible exposure to bloodborne pathogens.
Secure transfusion services is an equal opportunity employerIn compliance with the united states equal employment opportunity guidelines and the americans with disabilities act, secure transfusion services provides reasonable accommodation to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.
Job type: full-time
Pay: from $65,000.00 per year
Benefits:
401(k)
Dental insurance
Flexible schedule
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Monday to friday
Supplemental pay:
Bonus pay
Work location:
Fully remote
Work location: remote
