Our company is searching for a motivated and experienced Compliance Officer to guarantee that our business processes and transactions follow all relevant legal and internal guidelines, as well as to manage compliance for our Quality Assurance protocols. Your duties will include: reviewing employee work, developing company policies, and responding to policy violations; as well as ensuring the company functions in a legal and ethical manner while meeting its business goals. You will be responsible for developing new compliance programs, reviewing company policies, and advising management on possible risks. Since we are focused on pharmacogenomics (PGx) testing, experience in this field, knowledge of CLIA policies, and CAP/NY State policies is a must.
The ideal candidate will be professional, highly-analytical, and possess excellent written and verbal communication skills. To prosper in this role, you should be fluent in risk management, regulatory affairs and our industry’s principles, as well as proficient with Master Control.
- Oversees the development, implementation and maintenance of quality assurance systems and activities
- Oversees generation and review of documents used in GMP, GLP and CLIA processes.
- Oversees audits of vendors
- Stay abreast of developments within the field of compliance changes in the relevant regulatory and/or legal requirements
- Ensuring collaboration and commitment between Quality and other departments (Operations, Sales, Finance) in order to meet internal expectations.
- Plays a key role in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
- Review and manage our current legal compliance program and implement new policies and/or metrics if necessary.
- Develop and review company policies.
- Advise management on the company’s compliance with laws and regulations through detailed reports.
- Create and manage effective action plans in response to audit discoveries and compliance violations.
- Regularly audit company procedures, practices, and documents to identify possible weaknesses or risk.
- Assess company operations to determine compliance risk.
- Ensure all employees are educated on the latest regulations and processes.
- Resolve employee concerns about legal compliance.
- Bachelor’s degree in law, finance, business management or a related field.
- 3 – 5 years’ proven experience in a compliance officer role.
- Good knowledge of legal requirements and procedures.
- Detail oriented and strong written and verbal communication skills.
- Highly-analytical with strong attention to detail.
- Familiar with Microsoft Office applications
- Proficient with MasterControl