Quality Assurance Specialist (Remote-US) at MERIT CRO Inc

Madison, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Clinical Trials, Regulatory Compliance, Internal Audits, Vendor Management, Training, Documentation, Problem Solving, Attention to Detail, Interpersonal Skills, Organizational Skills, SOPs, CAPA, Change Control, Software Development Life Cycle, Communication

Industry

Biotechnology Research

Description

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 SUMMARY: 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. 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 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 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 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. The noise level in the work environment is usually quiet to moderate. Benefits Offered: 401(k), Dental insurance, Disability insurance, Health insurance, Life insurance, Paid time off, and 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 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.

Responsibilities

The Quality Assurance Specialist collaborates with Operations and the Quality Assurance Manager to maintain and implement the Quality Management System. They perform internal audits, vendor assessments, and assist with client audits while ensuring compliance with regulatory requirements.