Regulatory Affairs- Compliance Specialist

Regulatory Affairs- Compliance Specialist Hanford Pharmaceuticals - 2.3 Syracuse, NY Job Details Full-time $60,000 - $75,000 a year 17 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Document control within pharmaceutical industry Basic math Drug regulation Research Bachelor's degree Attention to detail Typing FDA regulations Full Job Description Job Summary We are seeking a dynamic and detail-oriented Regulatory Affairs - Compliance Specialist to join our team. The person in this role will manage and maintain the electronic document system, including creating, tracking, updating, and releasing compliance documents such as SOPs, lab methods, safety and HR policies, standards, training materials, and bills of materials. They will support compliance activities such as audits, document control, KPIs, complaints, deviations, and annual product reviews. The RA Compliance Specialist will ensure company documentation meets regulatory and customer requirements and recommend improvements as needed. They will also assist with regulatory research and provide information for agencies like the FDA and state authorities. Additionally, responsibilities will include performing general administrative and clerical tasks, including data entry and cross-department support. Responsibilities Maintain the

Electronic Management System:

Direct, prepare, route, track, supersede, submit, maintain, and archive compliance documents within the system. Provide coaching to co-workers in system use and task completion. Assist with

Quality Assurance/Compliance Department Functions:

Assist Quality Assurance department in audits (internal, regulatory bodies, vendor, and customer). Assist with compiling quarterly KPI metric reports. Assist with complaint processing, both material and customer complaints. Assist with documentation review and issuance as needed or required. Assist with

Corrective Action Tracking:

Assign variance and inspection report tracking numbers. Input same and summary information into respective databases and issue reports on same and for the Corrective Action Request (CAR) system.

Perform Administrative Support Functions:

Type correspondence, reports, and numerical data using word processing software. Complete data entry in various databases and spreadsheets including but not limited to Master Control, FileMaker Pro, MP2, and Excel. Record meeting minutes for various intra-departmental committee meetings related to quality/compliance topics. Compile statistical reports. Recommend new procedures based on own analysis of problems. Education/Experience/Skills Bachelor's Degree in science or equivalent experience. Proven experience in regulatory affairs within the healthcare or pharmaceutical industry, with a strong understanding of FDA regulations. Minimum Previous Experience to include at least 2 years' experience with document management systems in a regulated environment. Proficient in Microsoft Office, spreadsheets, document management systems, and databases Detail-oriented with strong organizational and multitasking abilities Able to work efficiently in a fast-paced environment with high accuracy Professional and courteous in interactions with all levels of staff Maintains strict confidentiality Basic math skills, including working with percentages, ratios, and data interpretation Strong problem-solving skills and ability to follow various types of instructions Capable of reading and interpreting business, technical, and regulatory documents Able to prepare reports and effectively present information to others

Pay:

$60,000.00 - $75,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person