Quality Control Coordinator

Position Description :

SUMMARY :

The Quality Control Coordinator, is responsible for establishing and maintaining a good working relationship with recovery / collection agencies and other professionals at Sequence LifeScience. They are also the primary resource for internal support for affected departments. This position will identify continuous process improvement areas, in compliance with cGMP, cGTP, GLP processes, and documentation for quality & donor services activities. Provide world-class customer service for both internal and external customers by capturing and being responsive to the voice of the customer (including donors) through established feedback channels to resolve issues and drive satisfaction by the SLS customer engagement, feedback, and complaint processes. Has the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, administrative and organizational skills, and the ability to maintain a realistic balance among multiple priorities. The Quality Control Coordinator will have the ability to work independently and must be able to work under pressure at times to handle a wide variety of activities. The Quality Control Coordinator position will report to the QA / RA Vice President.

DUTIES AND RESPONSIBILITIES :

Assist with review of all recovery / collection documentation and relevant medical records to ensure compliance with Sequence Life Science Tisue Bank , AATB standards, as well as FDA and state regulations to determine donor eligibility.

Communicate with Tissue Recovery partners on pending items required to complete donor eligibility documentation.

Maintain confidentiality of all records and information, which pertains to donor specimens, employees, the organization, and any client information that may be proprietary.

Collaborate with cross-functional operational and quality staff in other business units across affiliated companies.

As needed, follow up with partner recovery agency to ensure timely collection of recovery documentation.

Understanding serology test requirements and for tracking donor serology testing to ensure that appropriate testing was performed by a qualified lab.

Assist with routing donor charts to Medical Director for eligibility determination.

Monitoring and analyzing data

Assists with entry of information into the tissue bank database and electronic donor record storage system.

Assist with the maintenance of records and data collection to help ensure all required elements of the Quality System are met.

Assist with filing, tracking, routing and maintenance of tissue bank policies, procedures, division partner profiles, and guidelines.

Assist with the coordination and inspection of product ensuring compliance.

Maintain a close working relationship with appropriate Executive Management keeping them informed of issues.

Provides general administrative and clerical support including mailing, scanning, faxing, copying and data entry.

Maintains confidentiality of all records and information, which pertains to donors, families, employees, the organization, and related areas.

Perform other duties to support Quality staff as needed.

Skills & Abilities :

Ability to maintain a high level of accuracy in preparing and entering information.

Excellent grammar and spelling are a must.

Must have strong computer skills (MS Suite).

Honest, trustworthy, and respectful.

Possess strong written, verbal, and interpersonal communication skills.

Demonstrate experience utilizing critical judgment and analytical skills.

Works well under pressure with strict deadlines.

Demonstrate experience managing multiple projects simultaneously with strong attention to detail.

QUALIFICATIONS : Minimum Required :

High school diploma or equivalent with 2 yrs Quality experience

Medical Technology is preferred.

Work requires familiarity with medical terminology and ability to review / interpret in patient medical / hospital records.

Requires strong computer, communication and writing skills in order to produce business level correspondence, audit reports, SOPs and presentations.

Requires the mental ability and knowledge to assist in the internal and external audits.

Requires the mental ability to analyze documentation and identify breaches in policy.

Requires excellent organizational skills, ability to pay attention to detail and multi-task.

Work requires strong computer, communication and writing skills.

Work requires the ability to construct and produce business level correspondence.

Other Required :

Experience interpreting and complying with worldwide cGxPs with an emphasis on cGMP, CGTP, GLP, FDA, AATB.

Must be able to acquire a working knowledge of donor suitability criteria and infectious disease testing.

Must be able to maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current (Good Tissue Practices), and regulatory requirements concerning all aspects of Tissue Service and Cadaver Lab Operations.

Must be able to have a working knowledge of regulations and standards for biologics, including but not limited to HCTPs or regulated industries.

COMPETENCIES :

Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.

Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethics; Upholds organizational values.

Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.

Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.

Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.

Planning / Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.

Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.

Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

PHYSICAL DEMANDS AND WORK ENVIRONMENT :

Occasionally required to stand

Continually required to walk

Frequently required to sit

Frequently required to talk or hear

Occasional exposure to bloodborne and airborne pathogens or infectious materials along with occasional exposure to cadaveric specimens.

ACKNOWLEDGEMENT (Optional)

I have read the foregoing job description and understand the responsibilities of the job. I agree that I can perform the essential duties of this position.