Quality Assurance, Regulatory Compliance, and Documentation Specialist

Job Overview
The QA and Regulatory Compliance and Documentation Specialist will play a vital role in supporting the Quality and Regulatory programs, cGXP compliance and documentation, and Quality System. This role will support all aspects of QA and Regulatory Compliance and Documentation, perform routine QA procedures, review, and verify QA/QC operations and records, and ensure compliance with applicable regulations. The ideal candidate will have experience with Quality Systems and documentation, environmental and personnel monitoring, aseptic and GMP production, and basic knowledge of cell culture and procedures used with human cells and cell-based products. This position requires meticulous attention to detail, proficient technical writing, and the ability to draft and review Standard Operating Procedures (SOPs), material specifications, processing batch records and other QA documents, records and reports. This role supports product realization and compliance with the company’s quality management system and applicable regulations.

DUTIES AND RESPONSIBILITIES:

This position should be capable of supporting multiple projects with excellent organization, flexibility, and time-management. This position requires the capacity to handle multiple tasks and responsibilities, which include:

Quality Assurance

· Participate in drafting, reviewing, updating, and maintaining our existing libraries of SOPs, forms, logs, and master batch records needed to maintain adherence with applicable regulations.

· Issue and review Production Batch Records.

· Ensure control of processing materials by verifying all test reports and/or Certificates of Analysis/Compliance are available and meet specifications.

· Support environmental and personnel monitoring program.

· Support vendor management program.

· Develop and maintain record keeping and tracking tools for quality and regulatory compliance.

· Participate in preparing new documents as required for the quality system and regulatory compliance/submissions, including reports, summaries, templates, spreadsheets, and validations.

· Implement and support GDP, process improvements, quality training, document management, document/change control, deviation management.

· Assist in tracking and documenting deviations, nonconformances, and corrective and preventive actions (CAPA).

· Assist in implementing CAPAs.

· Participate in internal audits and investigate/document nonconformances and CAPAs as needed.

· Organize documents and draft summaries/tables based on relevant documents and data for regulatory submissions.

· Assist in reviewing data documentation to ensure completeness, accuracy, and compliance with quality standards.

· Compile and organize documents for record retention according to regulatory requirements.

· Perform additional ad hoc projects, as appropriate.

Note: This is NOT an all-inclusive list of responsibilities.

QUALIFICATIONS:

· Bachelor’s degree in basic science (cell biology, molecular biology, biochemistry), clinical science, or data science

· 2 years of work experience in quality documentation or regulatory compliance in academia or preferably in biotech or pharmaceutical industry.

· 2 years of experience in QA, QC, or the development and implementation of a quality system.

· Working knowledge of FDA regulations, ICH guidelines, and requirements for cGMP, GTP, GDP, and GCP compliance as they relate to quality documentation and regulatory submissions.

· Exceptional attention to detail and accuracy in documentation, as well as in oral and written communications; excellent written and spoken English.

· Experience with both paper-based documentation system and electronic documentation systems; flexibility and problem-solving skills are a plus.

· Working knowledge of standard scientific, analytical, and statistical principles.

· Strong organizational skills to work on multiple tasks as assigned, follow priorities, communicate, and meet timelines.

· Ability to take direction, ask questions, and work independently as instructed on tasks.

· High standards of organization, accountability, time management, integrity, and work ethic.

· Commitment to quality, accuracy, efficiency, and communication.

· Self-motivated and willing to learn and grow with a small company.

· Proficient in Microsoft Office Suite and Adobe Acrobat Pro.

COMPETENCIES:

• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
• Attendance/Punctuality – Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• 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.
• Interpersonal Skills – Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas.
• Motivation – Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Oral Communication – Speaks clearly and persuasively in positive and negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• 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.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Must be able to comfortably carry up to 20 pounds
• Frequently required to stand.
• Frequently required to walk.
• Continually required to sit.
• Occasional donning of cleanroom attire.

Pay: From $60,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $60,000