Overview
QA/QC-Commissioning Support Specialist Jobs in Remote at Vertex Innovations
JOB SUMMARY
The Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organization’s processes. Ensuring the business maintains compliance with all applicable Federal, State, Local, and Industry regulations and standards.
DUTIES/ RESPONSIBILITIES
Responsible for ensuring the Company is compliant with all applicable regulations (Local, State, Federal, OSHA and other applicable agencies) and internal policies.
Provide guidance and mentor direct reports to grow the QA department.
Develop, operate, and maintain the effectiveness of the Quality Management System, the processes/procedures; Document Control, Deviations, Change Control, Internal Auditing, and Quality Management Review.
Conduct internal audits and report results to site leadership.
Lead Process Improvement activities within the QA department and across other departments to streamline and improve existing processes to eliminate non-value-added activities.
Communicate all quality related issues and trends to site leadership and provide periodic reports on quality assurance matters.
Support regulatory inspections and draft/coordinate responses (if required) to ensure the site is compliant with regulatory requirements.
Maintain the approved supplier list and ensure all materials received and services performed are from approved suppliers and conform to specifications.
Communicates quality standards and parameters to QA team and other appropriate staff.
Reviews client/ customer feedback on processes and partner with the appropriate team if changes are needed.
Performs other related duties as assigned.
SUPERVISION RESPONSIBILITIES
Hires and trains quality assurance staff
Oversee the daily workflow and schedules of the department.
Conduct performance evaluations that are timely and constructive.
Handles discipline and termination of employees in accordance with company policy.
EDUCATION AND EXPERIENCE:
Bachelor’s degree in life sciences, engineering, or related field. Advanced degree preferred.
3+ years of proven experience of Quality Management experience.
Process improvement/Lean Six Sigma/Agile methodology experience preferred.
Strong working knowledge of global GMP/GLP requirements, regulations, and guidance.
REQUIRED SKILLS/ABILITIES
Ability to work effectively with cross-functional teams
Excellent leadership, communication, and interpersonal skills.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively as part of a multidisciplinary team.
Proficiency in MS Office Suite.
Excellent time management skills with a proven ability to meet deadlines.
Excellent organizational skills and attention to detail.
Bilingual in English and Spanish preferred.
PHYSICAL REQUIREMENTS
Prolonged periods of sitting at a desk and working on a computer
Must be able to lift 15 pounds.
Ability to work for short periods of time in Florida outdoor conditions.
Title: QA/QC-Commissioning Support Specialist
Company: Vertex Innovations
Location: Remote
