Quality Assurance Specialist

Quality Assurance Specialist Position Summary Cone Bioproducts is seeking a Quality Assurance Specialist to support and maintain company quality standards throughout laboratory and production operations. This role helps ensure products are manufactured, documented, and released in compliance with company procedures, safety standards, and regulatory requirements. The ideal candidate will have experience working in a regulated environment and be comfortable reviewing documentation, supporting audits, monitoring compliance, and assisting with quality investigations and corrective actions. Key Responsibilities Monitor laboratory and production areas to ensure compliance with company policies, SOPs, safety requirements, and Good Manufacturing Practices (GMP). Review batch records, production documentation, logs, and quality records for accuracy and completeness. Assist with investigations related to deviations, non-conformances, and quality concerns. Support Corrective and Preventive Actions (CAPA) and follow-up activities. Maintain organized quality documentation and assist with document control processes. Participate in internal audits, inspections, and regulatory readiness activities. Assist with employee training related to quality procedures, compliance, and safety practices. Verify materials and finished products meet company specifications and customer requirements before release. Work closely with Production, Laboratory, and Management teams to support continuous improvement initiatives. Perform additional quality-related duties as assigned. Qualifications Associate degree or Bachelor's degree in Biology, Chemistry, Life Sciences, or a related field preferred. 2+ years of experience in Quality Assurance, Quality Control, laboratory, or regulated manufacturing environments preferred. Basic understanding of

GMP, FDA 21 CFR 820

regulations, ISO 13485 standards, or quality systems preferred. Strong attention to detail and organizational skills. Ability to manage multiple tasks in a fast-paced manufacturing environment. Good written and verbal communication skills. Proficient in basic computer systems and documentation practices. Preferred Skills Experience in biotechnology, medical device, pharmaceutical, food manufacturing, or related regulated industries. Familiarity with CAPA, audits, deviation investigations, and document control. Ability to work independently and collaboratively within a team environment. Work Environment Manufacturing and laboratory setting. May require standing, walking, and working around biological materials and laboratory equipment. Must follow company PPE, safety, and compliance requirements at all times.

Job Type:

Full-time Pay:

From $50,000.00 per year

Benefits:

Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person