The Compliance Specialist provides guidance and ensures compliance with ISO13485 & 21 CFR Part 820 and applicable good manufacturing practice regulations within the company. Also provides support to delivery, drive and maintain effective Product Quality Surveillance.
Responsibilities:
- Perform quality inspections of raw and in-process materials and finished products at various stages of the manufacturing process.
- Monitor routine manufacturing operations for conformance to applicable procedures and report all deviations.
- Review/approval of Final Reports of Non-Conforming, Investigations (OOS), Complaints and CAPA’s
- Maintain awareness of evolving industry and regulatory trends/regulations
- Ensure that plan, policies and procedures comply with regulatory, investor and agency requirements and are incorporated into daily operating procedures.
- Responsible for documentation quality review/approval or audits, documentation maintenance and archival, quality inspections of product, and participating on internal assessments.
- Responsible for review labeling and promotional material, in compliance with established procedures.
- Performing batch record review and compliance assessments prior to product release.
- Supporting routine batch disposition.
- Work with cross functional groups relative to GMP issues, project plans, due dates, and problem identification and resolution.
- Support internal and external audits.
- Ensure compliance requirements and enforcement are balanced with customer needs and continuous improvement efforts.
- Provide Quality guidance on GMP regulatory requirements (including 21CFR part 820, and ISO 13485:2016), including training of personnel.
- Ensure effective periodic Product Quality Review.
- Analyze data to highlight trends that may indicate the need for corrective actions or opportunities for improvement.
Requirements
Education: Bachelor’s Degree in a scientific, technical, or compliance discipline
Preferred Qualifications:
- 2-5 years in Quality Assurance or another related function in the pharmaceutical, medical device, nutritional or related industry experience.
- 3 plus years in Quality Compliance
Knowledge
- Knowledge and understanding of the current Good Manufacturing Practices (GMP) and ISO 13485:2016
- Basic understanding of Biopharmaceutical Manufacturing, Analytical Chemistry and Chemical Manufacturing processes.
- QMS Feedback systems, including but not limited to quality event reporting, investigations, CAPAs, feedback, complaints, adverse event reporting.
- QMS audits
- Knowledge and understanding of practical quality assurance in the manufacturing environment, laboratory controls and safety.
- Ability to read and understand procedures and other controlled documents.
- Good written and verbal communication skills, interpersonal skills, and technical writing skills
Expertise
- cGMP medical device requirements from USA 21 CFR § 820 and ISO 13485
- QMS design and operations
- QMS Feedback systems, including but not limited to quality event reporting, investigations, CAPAs, feedback, complaints, adverse event reporting.
- QMS audits
- Technical writing and communication
- Electronic Quality Management Systems
- Good Documentation Practices (GDP) and data integrity
Proficiency
- Analytical Chemistry and Chemical Manufacturing processes.
- Laboratory audits
- Technical problem-solving
- Minitab, Excel, or other statistical software
- Statistics principles and data analysis
- Microsoft Office suite
Skills
· Attention to Detail – Ability to determine the accuracy, neatness, and thoroughness of work assigned and/or make general observations.
· Adaptable – Willingness to be flexible. Open minded to new processes or changes in direction.
· Team Player – Team oriented, capable of building relationships with peers and managers in a productive and proactive manner.
· Efficiency & Organization – Plans, organizes, schedules, and budgets precisely with keen attention to detail. Focuses on key priorities. Produces significant output with minimal wasted effort.
Benefits
· Paid Vacation, Sick, & Holidays
· Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
· Company Paid Life and Short-Term Disability Coverage
· Work/Life Employee Assistance Program
· 401(k) & Roth Retirement Savings Plan with company match up to 5%
· Monthly MetroCard Reimbursement
The salary range for this role is $70,000-$80,000.
Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.
