We are seeking an experienced Compliance Specialist. This position will be responsible for the oversight of regulatory compliance activities at all facilities. This position will oversee the compliance document control personnel. Will monitor associate work load, attendance and work performance.
- Develops, initiates, maintains, and revises policies and procedures for the general operation of the Quality System and its related activities to follow proper code of regulation.
- Develops and periodically reviews and updates Standards of Conduct to ensure continuing currency and relevance in providing guidance to management and employees.
- Collaborates with other departments (e.g., Risk Management, Internal Audit, Employee Services, etc.) to direct compliance issues to appropriate existing channels for investigation and resolution.
- Continuously monitors and updates senior management on developing quality and regulatory matters.
- Generates audit report for inspection performed.
- Assists in complaint, non-conformance, and OOS investigations.
- Assists in regulatory/customer audits.
- Trends compliance/quality data.
- Assists in training plant employees.
- Assists in compliance/quality related matters.
- Bachelor’s degree in science is preferred and/or 3 years of Quality/Regulatory Compliance experience in the nutraceutical, pharmaceutical, medical device or biotech industry.
- Working knowledge of cGMPs and FDA regulations as it pertains to document control and quality assurance.
- Strong documentation skills related to Good Documentation Practices, including the ability to edit and proof documents.
- Previous experience in preparing, hosting, and responding to regulatory agencies and client audits
- Knowledge of conducting internal and external audits
- Ability to adapt in a fast pace work environment and be able to deal with multiple critical tasks/issues
- Must have excellent written and verbal communication skills
- Assist with interpreting and applying regulatory requirements and industry best practices
- Experience in problem solving and root cause analysis
- Ability to form, participate in and lead teams to accomplish goals and objectives
- Must demonstrate flexibility to changing priorities, work schedule, and the needs of the business
- ASQ CQA and/or CHA certification preferred.
What We Offer:
- Competitive Wages
- Medical & Dental (company pays 75% of employees HMO plans)
- Discounted Vision
- 401k match up to 3%
- Life Insurance
- Paid Holidays
- Vacation Days
- Sick Days
Robinson Pharma is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status with respect to recruitment, hiring, promotion and other terms and conditions of employment. Robinson Pharma takes affirmative action in support of this policy to employ and advance in employment individuals who are minorities, women, disabled, and veterans.
This is a non-management position
This is a full time position