The Document Compliance Specialist/Quality Analyst will be responsible for performing all assigned duties related to the Quality Management System and works directly with personnel to ensure quality systems compliance to all ISO 13485:2016, ISO15189:2022, CAP, CLEP, and CLIA regulations to ensure that product requirements are managed and traced per quality procedures.
The Compliance Specialist is responsible for working with personnel to ensure consistency of documentation practices across the company following Good Documentation Practices, (GDP).
This role ensures that quality documents and data are managed according to all applicable standards and regulations and will assist with continuing certification to all regulatory agencies and Good Laboratory Practice (GLP) standards.
Want more jobs like this?
Get jobs in Buffalo, NY delivered to your inbox every week.
PRIMARY RESPONSIBILITIES:
- Provide guidance in the areas of quality management to all departments.
- Aid in providing guidance for implementing quality policies and procedures.
- Collect summary data for management review; create graphs, charts, tables, power point presentations, etc.
- Assisting with both internal and external audits.
- Adhering to regulatory requirements: comply with applicable federal, state, and local regulations, and the requirements of accrediting organizations.
- Drafting, writing and proofreading Quality System and Regulatory documents.
- Working with personnel to ensure consistency of documentation practice across the company, including clinical and BioPharma projects
- Organizing an archiving system using company programs and applications.
- Labeling, sorting and categorizing documents for ease of use.
- Controlling access to documents.
- Removing documents that are obsolete.
POSITION REQUIREMENTS
- Degree in Clinical Laboratory Science, Communications, Business, Health Administration or related fields, with 1-2 years of relevant laboratory/quality experience also preferred.
- Knowledgeable and experienced in CAP/CLIA/CLEP/ISO regulations.
- Strong computer skills, including but not limited to the following Microsoft applications such as Excel, PowerPoint, Visio, and Word.
- Outstanding organizational and interpersonal skills.
- Attention to detail.
- Excellent written and verbal communication.
Position Location: 700 Ellicott Street, Buffalo, NY
Day position: Following training can be Hybrid with 3-5 days per week onsite based on Audits
Pay Range: $70,000 to $80,000 annually
The Compliance Specialist reports to the Sr. Director, Regulatory Affairs and Quality Assurance. The incumbent must have the education, experience and authority to discharge the responsibilities of the position and must have access to personnel at all levels of the organization as necessary. The Compliance Specialist/Quality Analyst makes routine contact with all organization departmental personnel.
FUNCTIONAL RESPONSIBILITIES
Must be familiar with a personal computer and pertinent Laboratory Quality System(s).
Must demonstrate the ability to work as cross functional team member.
Must demonstrate the ability to solve problems and interpret requirements.
Must demonstrate knowledge of regulatory agency requirements and standards.
MACHINES, TOOLS AND EQUIPMENT USED
Personal computer: MS Word™, MS Excel™, MS PowerPoint™ and others
Document Management Applications: MediaLab™
Product Design Software Applications: JAMA Connect™
Software Management Applications: JIRA™
Various office equipment as necessary
Position Location: 700 Ellicott Street, Buffalo, NY
Day position: Following training can be Hybrid with 3-5 days per week onsite based on Audits
Pay Range: $70,000 to $80,000 annually
All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility.
For more information about how we collect and store your personal data, please see our Privacy Statement.