Quality Assurance Senior Specialist na 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

Primary functions include collaborating with Operations and the Quality Assurance Manager to maintain and lead the implementation of 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. Leads on-site client, regulatory, and certification audits and provides training and communications on regulatory requirements to all MERIT personnel. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

• 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
• Client and regulatory on-site visits and remote audits- schedules, manages, and acts as a MERIT representative as assigned.
• Internal audits – conducts internal audits and leads the development of the internal audit schedule.
• Vendor and Contractor qualifications and audits – leads vendor and contractor qualifications and audits including on-site audits, and vendor and contractor maintenance activities.
• Comply fully with MERIT policies and Standard Operating Procedures (SOPs)
• Collaborate with other departments, cross-functionally, to ensure consistency in training and re-training processes across the organization.
• Designs, develops, and delivers training exercises to meet training objectives
• Works with Human Resources and managerial staff to develop onboarding schedules and training matrices 
• Works directly with operations to recognize and lead process improvement initiatives
• Leads training and onboarding for all new QAC staff members
• Responsible for organizing and maintaining documentation within MediaLab for departmental training material and assisting staff with training file documentation
• Leads the development, recommendation, review and administration of policies, training and SOPs within Medialab. 
• 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 
• May support computerized system validation processes by reviewing and approving documents to verify all SOP and regulatory requirements are met
• 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

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:

Preferred BA or BS degree from a four-year colled or university, a minimum of five (5) years of quality assurance or training experience in the medical device, pharmaceutical, or a GxP industry or equivalent combination of education and experience. 

Preferred experience in clinical trial related field that includes ISO 27001 and 13485 certifications. 

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 in a team environment as a team member. Oral and written communication is clear, concise, and effective. 

Licenses or Certifications Required: 

None.

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. 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Benefits Offered: 

401(k)

Dental insurance

Disability insurance

Health insurance

Life insurance

Paid time off

Vision insurance

MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce. It is the employment policy and practice of MERIT CRO, Inc. to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.