Position Description:
JOB TITLE: Quality Assurance Specialist I
EMPLOYER: Sequence LifeScience
REPORTS TO: Quality & Regulatory Manager
SUMMARY: Sequence seeks a highly motivated and detail-oriented Quality Assurance Specialist I to join our team in a full-time capacity. Reporting to the Quality & Regulatory Manager, the successful candidate will be responsible for ensuring compliance with all applicable regulations and standards, designing and developing validations, and managing regulatory submissions and interactions with authorities. Beyond technical compliance, this role provides world-class customer service by capturing and responding to the voice of the customer -including donors- through established feedback channels in order to resolve issues and drive satisfaction in accordance with the SLS customer engagement, feedback, and complaint processes. The ideal candidate must exercise good judgment in a variety of situations, possess strong written and verbal communication skills, and demonstrate the organizational ability to balance multiple priorities independently while navigating a diverse range of projects from conception to completion.
DUTIES AND RESPONSIBILITIES:
- Develop and maintain a comprehensive understanding of applicable regulations and standards (FDA 1271 CFR, AATB, and ISO) and stay current with global regulatory developments and trends.
- Prepare and maintain regulatory submission documents to ensure timely filing; participate in meeting and official interactions with regulatory agencies.
- Assist with communicating with vendor representatives and suppliers to facilitate vendor qualifications.
- Assist with being a compliance & regulatory resource by providing required consultation and input for projects impacting quality, manufacturing, and distribution of HCT/Ps.
- Design and develop validation plans, protocols, data sheets for equipment qualifications and process validations.
- Develop & review protocols, validations, design plans, and new or revised SOPs to ensure compliance with internal standard operating procedures, and federal/local regulations.
- Manage change control processes and facilitate quality improvement projects and initiatives.
- Conduct investigations into non-conforming materials and manage quality events, including CAPAs, Deviations, Complaints, and SCARs.
- Conduct internal audits of quality systems and participate in external regulatory audits, implementing corrective actions where necessary.
- Identify and address unusual results and difficulties encountered in all phases of Sequence Operation activities to include purchased goods, environmental factors, mechanical problems or product-related issues.
- Maintain and facilitate the retention of QA documentation while ensuring strict confidentiality of all sensitive information.
- Provide general clerical support, including data entry, scanning, and mailing, to ensure efficient department operations.
- Maintain detailed records of quality assurance activities and prepare data presentations and reports for management review.
- Participate in quality improvement projects and initiatives.
- Maintain a close working relationship with appropriate management keeping them informed of issues.
- Serve as QA point of contact in multi departmental projects as assigned by QA/RA Manager.
- Train staff members as required and attend professional meetings, seminars, or workshops to maintain industry expertise.
- Perform other duties as assigned.
SUPERVISORY RESPONSIBILITIES:
- This job has no supervisory responsibilities.
QUALIFICATIONS:
- Knowledge of 21 CFR 1271 FDA regulations and ISO & AATB standards.
- Experience with document control and record keeping.
- Strong attention to detail and experience utilizing critical Judgement and analytical skills
- Excellent written and verbal communication skills. Excellent grammar and spelling a must.
- 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 Medical Device Operations.
- Must be able to design and plan Standard Operating Procedures (SOPs) and policies.
- Strong organizational and time management skills.
- Ability to work independently and collaboratively. Excellent communication and interpersonal skills.
- Demonstrate experience managing multiple projects simultaneously.
- Ability to maintain a high level of accuracy in preparing and entering information.
- Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat Pro, cloud-based eRegulatory platforms, and E-mail.
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 ethically; 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.
Education and Experience:
- High school diploma or equivalent with 2+ yrs Quality Assurance experience
- College with 1+ years in a similar related role.
Preferred:
- Bachelor's degree in biology, chemistry, or related field
- 1-2 years of experience in a quality assurance role in a regulated industry
- AATB Tissue Bank Certification (CTBS) preferred
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Frequently required to stand
- Continually required to walk
- Occasionally 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.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
