Compliance Specialist
About The Position
Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in good laboratory practices training of functional areas and assists in the development of training sessions. Ensures that privacy and security standards are met and adhered to. May coordinate activities and assist with interactions during regulatory agency inspections. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Assists with the corrective action implementation. May coordinate investigator site and clinical supplier vendor audits.
Requirements
- Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.
- Experience with SAP or equivalent ERP product and productivity software desired.
- Bachelors Degree (or equivalent experience) and/or 2-5 years of related experience or Masters Degree with no or little experience.
- Ability to travel domestically and internationally.
- Wear personal protective equipment (PPE) during audits on a manufacturing floor.
Nice To Haves
- Experience with SAP or equivalent ERP product and productivity software
Responsibilities
- Coordinate and prepare internal and external audits and compliance in accordance with regulatory standards.
- Collaborate with clients to develop positive and proactive approaches to regulatory compliance.
- Participate in good laboratory practices training of functional areas and assist in the development of training sessions.
- Ensure that privacy and security standards are met and adhered to.
- Coordinate activities and assist with interactions during regulatory agency inspections.
- Direct interaction with regulatory agencies on defined matters.
- Recommend strategies for earliest possible approvals of clinical trials applications.
- Assist with corrective action implementation.
- Coordinate investigator site and clinical supplier vendor audits.
Benefits
- Medical Insurance
- Dental/Vision
- 10 Paid Holidays
- PTO
- Employee Stock Purchase Plan
- 401K match
- Paid Parental Leave
- Short & Long-Term Disability and Life Insurance
- Competitive Pay
- Flexible Schedules
- Variety of Shift Options
- Free Safety Shoes
- Friendly Work Environment
- On-site Cafeteria, Company Nurse, Credit Union, and Gym
- Free Coffee and Soda
- Tuition Reimbursement
- Employee Referral Program
- Career Advancement Opportunities
- Employee Discounts
- EV Charging Stations
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
