Job Description
About Us: SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.
Job Summary: The Quality Assurance Associate will support the Quality Assurance department in ensuring that all pharmaceutical manufacturing processes and products meet regulatory standards and internal quality specifications. This role involves performing quality checks, maintaining documentation, and supporting compliance activities to ensure product integrity and safety.
Essential Job Duties and Responsibilities: - Quality Assurance Monitoring: Review and approve routine inspections and quality checks of raw materials, in-process samples, and finished products to ensure compliance with regulatory requirements and internal quality standards.
- Documentation and Reporting: Maintain accurate records of company activities, including test results, deviations, and corrective actions. Prepare and review quality documentation, including SOPs, batch records, and reports.
- Quality Management System: Maintain eQMS system including SOPs, Change Control, Deviation, Reports, and Protocols.
- Supplier Evaluation Process: Support the maintenance and introduction of suppliers including Approved Supplier List (ASL) and supplier audits.
- Compliance: Assist in the development and implementation of quality assurance procedures and guidelines. Ensure that manufacturing processes adhere to Good Manufacturing Practices (GMP) and other relevant regulations.
- Problem Solving: Investigate and resolve quality issues, including deviations and non-conformances. Collaborate with cross-functional teams to identify root causes and implement corrective and preventive actions.
- Audits and Inspections: Support internal and external audits by preparing necessary documentation and facilitating inspection processes. Assist in addressing audit findings and implementing recommendations.
- Training: Participate in training sessions and workshops to stay updated on industry regulations and best practices. Support training efforts for other team members on quality-related topics.
- Maintain the cGMP training program for the company through eQMS system.
- Provide support to the Quality Director in the development and implementation of strategic Quality initiatives.
- Act as backup to the Quality Director for meetings and oversight of the Quality department, as needed.
- Provide support for Complaint and Adverse Event resolution.
- Provide leadership and ownership in exposing and eliminating problems in areas of responsibility. Play an active role in process improvement and problem solving.
- Ensure proper communication of company policies such as safety, breaks, clean room protocol, etc.
- Other duties as required.
Essential Qualifications: - Minimum Bachelor's Degree required.
- 2-4 years of experience in a quality role within the pharmaceutical or related industry is preferred.
- Must have computer skills and familiarity with all Microsoft Office programs (i.e. Word, Excel, etc.).
- Strong understanding of GMP, FDA regulations, and other relevant industry standards.
- Proficiency in quality techniques and documentation practices.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and organizational skills.
- Effective communication skills and the ability to work collaboratively in a team environment.
ADA Requirements: - Stand, walk, bend, squat, twist, reach or otherwise move frequently
- Occasional repetitive motion and grasping
- Occasional climbing to reach areas on machines or racks
- Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently
- Typically sits, grasps items or performs keyboarding for occasional operation of a computer
- Exposure to typical machine shop physical hazards which may require respiratory protection
At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
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