Quality Validation Analyst BioStorage Technologies
THIS JOB HAS EXPIRED The statements below reflect the general details considered necessary to describe the major
responsibilities of the identified position and are not to be construed as a detailed description of
all the work requirements that may be inherent in the job.
The Quality Validation Analyst reports to the Associate Director of Quality Assurance and is
responsible for oversight of the company validation program to ensure compliance with federal
laws (21 CFR 11), GxP, and industry guidance documents.
The Quality Validation Analyst will create and implement policies, procedures, and protocols
which result in attaining validation and quality goals while meeting GxP requirements. In
addition to the validation program, the Quality Validation Analyst will also participate in other
Quality Assurance functions such as Quality audits, investigation reports, CAPA, reporting
metrics, and continuous improvement initiatives.
Major Responsibilities, Activities and Task Statements:
1. With the oversight of the Associate Director of Quality Assurance, maintain the facility
validation program to be in compliance with 21 CFR part 11, GAMP, and industry guidance
2. Review and create validation documents including, but not limited to, Validation Master Plan
(VMP), environmental temperature mapping, remote alarm monitoring systems, company
software systems, IT infrastructure, and change control.
3. Provide facility oversight to ensure that all applicable equipment is properly calibrated,
documented, and traceable to national calibration standards.
4. Participate in committees to procure new (or revised) hardware/software systems including
establishment of User Requirement Specifications (URS), Functional Requirement
Specifications (FRS), Design Specifications (DS), and validation protocol design.
5. Keep up-to-date in fields of validation and GxP utilizing current literature and attending
workshops and seminars. 6. Collaborate with company IT and facilities department to develop and implement
compliance and appropriate Quality control policies.
7. Review all policies and procedures to assure appropriate best practices resulting in
standardized and streamlined global processes and improved quality. Act as Associate
Director of Quality Assurance?s designee for approval of policies, procedures and validation
documents during their absence.
8. Responsible for assisting with and responding to client audits and visits in addition to
9. Communicate with Associate Director of Quality Assurance on significant changes or
concerns pertaining to compliance, change control, or GxP guidelines.
10. Participate in investigations due to non-conformities and manage and drive the resolution of
client issues via CAPA. Promote and drive continuous process improvement.
11. Provide training of employees on validation and quality related topics.
12. Assist with implementation of validation standards in global branches of BioStorage
13. Participate in the development and updates of Quality and Validation metrics.
14. Lead member of Change Management Team including equipment and computerized
Minor Responsibilities, Activities and Task Statements:
1. Comply with established communications code concerning BioStorage Technologies business
and patient confidential information.
2. Implement and monitor processes that ensure appropriate escalation of issues and
continuous, appropriate communication of issues across the organization.
3. Participate on committees and public relations projects as requested.
4. Attend meetings as required such as I service meetings, committee meetings, department
head meetings, etc.
5. Maintain department records.
6. Cooperate with BioStorage Technologies staff to achieve goals and maintain harmonious
working relationships among employees.
7. Requisition supplies, equipment and forms needed in the department.
8. Perform other duties as directed by the Associate Director of Quality Assurance.
? Four-year degree
? 3-5 years of validation experience in a pharmaceutical (or equivalent) environment
? 2 years of Quality Assurance experience
? Strong analytical skills and the ability to think creatively.
? Excellent leadership skills and ability to work across organization.
? Strong communication and interpersonal skills.
? Excellent in Good Laboratory Practices, Good Manufacturing Practices or Good Tissue
? Exposure to biological safety policies and guidelines.
? Experience in the areas of Quality Improvement and Quality Assurance.
? Demonstrated high level of initiative and ability to work independently.
? Proven ability to work effectively with teams.
? Competency with Microsoft Office products including Outlook, Word and PowerPoint. Preferred
? 4 year degree to be biology science related.
? Active participant in continuous improvement initiatives.
? Experience writing and managing SOP?s and Quality Assurance and Business Policies.
? Experience with FDA and/or customer audits in an FDA regulated environment.
? Fluency with German and/or Chinese languages
Organizational Core Competencies:
? Guided by a set of core values and beliefs to guide behavior and performance
? Represents information accurately and openly
? Demonstrates fairness in dealing with others
? Uses appropriate judgment in maintaining confidentiality
? Displays consistent loyalty to company values even under pressure
? Acts objectively and inspires trust
? Considers the client perspective when creating policies, procedures and solutions.
? Attentive and responsive to customer requests.
? Listens to and anticipates needs of the customer.
? Identifies, influences and manages customer expectations.
? Aligns priorities with the customer?s priorities.
? Acts with a sense of urgency on behalf of customer needs.
? Recognizes that building relationships are critical for success-internal and external.
Accountability to Team and Self
? Is open to learning ones tendencies ? areas of strengths and areas of development
knows ones strengths and limits
? Understand behavior impact on others
? Acknowledges accountability for performance and its influence on team
? Recognition that intent and actions should be aligned, with sensitivity to others
? Demonstrates support for the group over personal wishes
? Anticipates. identifies, confronts and overcomes barriers in order to successfully
complete a task or project.
? Focuses on outcomes rather than activities.
? Demonstrates personal contribution to accomplish goals.
? Drives and produces efficient solutions ? actively pursues process improvement.
? Consistently delivers on commitments and goals.
? Drives quality standards and maintains these standards.
? Follow established guidelines for quality assurance.
? Takes accountability for mistakes through self-reporting, corrective action, and
? Consistently demonstrates accuracy, compliance and gold standards service
? Ambassador of quality throughout the organization. Working Conditions
Employee will be working in a facility with potentially infectious materials. Employee will be
responsible for maintaining a clean work environment and enforce and follow universal
precautions for blood borne pathogens when working in an area considered to be potentially
Some travel, including international travel may be required.
||2655 Fortune Circle West |
Indianapolis, IN 46241
THIS JOB HAS EXPIRED