What are the responsibilities and job description for the Regulatory and Quality Compliance Specialist II position at Swiss American CDMO?
Job Details
Description
Position Summary: The Regulatory Compliance Specialist II will be responsible for assisting with internal and supplier audits, as well as assisting with other tasks within the Regulatory and Quality departments. The Regulatory and Quality Compliance Specialist II will support and assist the Senior Regulatory and Quality Specialist and Regulatory and Compliance Manager with daily tasks associated with Swiss American CDMO, LLC’s regulatory and compliance.
Essential Duties and Responsibilities:
- Plan, execute, and report on internal audits of various departments as required per company QMS, ISO, and FDA requirements.
- Plan, execute, and report on key suppliers to verify the quality and compliance of materials, components, or outsourced processes.
- Evaluate and audit manufacturing processes for efficiency, accuracy, and compliance with regulatory guidelines (GMP, ISO standards, FDA, CFR).
- Prepare comprehensive audit reports highlighting audit findings, risks, control weaknesses, and recommendations for improvements to senior management.
- Monitor the implementation of audit recommendations to ensure timely corrective actions and continuous improvement.
- Stay updated on audit best practices, industry trends, and regulatory changes to enhance the internal/external audit functions.
- Provides regulatory input into change controls and CAPA with limited scope to regulatory issues.
- Coordinates responses to failures including next steps, CAPA decision, report ability decision and trend analysis.
- Assist with Complaint Handling process.
- Maintains knowledge; understand cGMPs and current regulatory expectations regarding complaint handling and reporting, trend analysis and overall Quality Systems.
- Participate in site post-market surveillance activities.
- Participate in pharmacovigilance activities.
- Assist with Annual Product Review of Drug Products.
- Assist with Design File management/maintenance.
- Assists in developing procedures to ensure regulatory compliance.
- Obtains regulatory certificates as requested (GMP, Certificate of Foreign Government, CFS, etc.)
- Facilitates the registration and renewal process for state manufacturing licenses both inside and outside of Texas.
- Assist in data analysis and preparation of Management Review.
- Assist with creating and/or maintaining technical files as necessary to aid clients in obtaining and sustaining product approval.
- Responsible for working with other employees to resolve compliance issues as appropriate.
- Provide cross training for other team members to ensure continuity of business operations.
- Assist with the review of quarterly surveys/assessments for Swiss American suppliers.
- Attend and participate in meetings as required.
- Maintains professional growth and development through seminars, workshops and profession affiliations to keep abreast of latest trends In Industry.
- Other duties may be assigned.
Qualifications
Essential Skills and Qualifications:
- Bachelor’s degree in science, Engineering, Quality Assurance, preferred
- Minimum of 2 years of experience in auditing, quality assurance, quality control, or related field, preferably within a regulated industry such as medical devices, pharmaceuticals, or manufacturing
- Auditor Certification [Certified Internal Auditor (CIA), ASQ Certified Quality Auditor (CQA), Regulatory Affairs Professionals Society (RAPS), etc.], preferred
- Proficiency in CAPA management systems and tools
- Strong understanding of manufacturing operations and compliance requirements, ensuring the company adheres to industry regulations and internal policies.
- Excellent analytical, problem-solving, and decision-making abilities
- Ability to manage multiple audits and projects simultaneously
- Strong verbal and written communication skills
- Possesses a strong understanding of cGMPs, complaint handling regulations, pharmacovigilance, and quality systems.
- Excellent communication and interpersonal skills to lead and facilitate timely responses to complaints.
- Ability to collaborate effectively with cross-functional teams (Quality, Operations) to ensure compliance.
- Meticulous attention to detail for accuracy and adherence to procedures.
- Proficient in Microsoft Office Suite & web tools.
Desired Skills and Qualifications
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- 2 years Industry experience
Key Competencies
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- Integrity and ethical conduct
- Critical thinking and analytical mindset
- Ability to work independently and as part of a team
- Strong organizational and time management skills
- Confidentiality and discretion
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
