Clinical Trials Quality Assurance Specialist

at  MERIT CRO Inc

Description:
MERIT, CRO Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities.
We are seeking a Clinical Trials Quality Assurance Specialist whose primary functions include collaborating with Operations and the Quality Assurance Manager to maintain and assist with implementing the Quality Management System (QMS). Ensures the compliance of appropriate quality management tools, implements the related process. Performs internal audits and contractor and vendor assessments including qualifications, on-site audits, and maintenance activities. Assists with on-site client audits and provides training and communications on regulatory requirements to MERIT personnel.

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND EXPERIENCE:

BA or BS degree from a four-year college or university with related experience and/or training in a health care, clinical research or service-related environment, or equivalent combination of education and experience.
A minimum of 2 years’ experience in quality assurance in the medical device, pharmaceutical or GxP industry.

OTHER SKILLS AND ABILITIES:

Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess Company needs and work independently. Computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software. Must be able to project a professional attitude and image appropriate for the work environment.
Ability to participate and contribute to a team environment as a team member. Oral and written communication is clear, concise, and effective.

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands; to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

• Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss, direct and manage task items with the project managers and team members
• Comply fully with MERIT policies and Standard Operating Procedures (SOPs)
• Internal audits – conducts internal audits and assists in the development of the internal audit schedule.
• Client and regulatory on-site visits and audits- assists with scheduling and managing audits as assigned.
• Vendor and Contractor qualifications and audits – conduct vendor and contractor qualifications and audits including on-site audits, and vendor and contractor maintenance activities.
• Leads the development, recommendation, review and administration of policies, training and SOPs
• Provide training for implementation of internal and regulatory requirements
• Ensure that SOPs are being followed during daily operations: CAPA, deviations, non-conformances, document control, change control, software development life cycle, validations, training, security, and documentation
• Interpret and assist in implementing regulatory guidelines into MERIT QMS
• Responsible for audit responses within framework of internal SOPs and client due dates
• Other responsibilities may be assigned as required
  The following are the essential functions of the position but are not all-inclusive.
  Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
  Demonstrates a commitment to maintain safe, clean and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.
  Requirements: