Sr. Quality Control Specialist

Job Description

Job Description

Benefits Offered :

Medical

Dental

Vision

401K with company match

PTO

11 Paid Holidays

Breakfast provided Monday - Friday

Job Summary :

Biovation Labs is seeking a Senior Quality Control Specialist to join our team. The Senior QC Specialist provides advanced support for quality operations under the guidance of the QC Manager. This role leads key operational initiatives, including environmental monitoring, SOP updates, specification support, inspections, and stability program management. The Senior QC Specialist ensures compliance with cGMP, supports OOS investigations, and manages critical documentation and QMS activities, including ingredient data and raw material specifications. This role also contributes to continuous improvement initiatives.

Job Duties & Responsibilities :

Continuos Improvement & Quality Initiatives

• Support continuous improvement initiatives to enhance operational efficiency and product quality.
• Monitor QC metrics and trends and support process improvement initiatives.
• Prepare and summarize quality data, including failed processes, stability results, recalls, corrective actions, and re-validations.

Environmental Monitoring Program (EMP)

• Oversee the design, implementation, and maintenance of an effective Environmental Monitoring Plan (EMP)
• Conduct swabbing and sampling activities at defined frequencies, analyze results, and implement appropriate containment measures for affected areas.
• Develop, update, and ensure adherence to SOPs governing environmental monitoring procedures and specifications.

Investigations and Corrective Actions

• Participate in and support CAPA, OOS, NCR, and deviation investigations under the QC Manager’s direction.
• Assist with investigation closure activities, ensuring appropriate documentation and follow-up actions.
• Support internal audit preparation and ensure timely completion of related documentation.

Inspections and Product Evaluation

• Conduct inspections of finished goods, in-process materials, and components to ensure compliance with specifications.
• Verify product weights, labeling, and documentation accuracy.
• Provide cross-funtional QC support to production operations as needed.

Quality Management System (QMS) & Documentation

• Upload and maintain ingredient information, raw material data, and specifications within the QMS.
• Ensure accurate and current document control for specifications, test methosds, and supporting data.
• Support the review and release of component materials and finished goods.
• Ensure full compliance with cGMP, SOPs, and company quality policies.

Stability Program Management

• Administer the stability program, including sample tracking, test scheduling, data recording, and documentation and results.
• Compile and evaluate stability data to support product shelf-life and quality decisions.

Other Responsibilities

• Participate in internal audits and regulatory inspections as needed.
• Maintain a strong working knowledge of evolving regulatory and company requirements.
• Perform other duties as assigned by the QC Manager or Quality leadership team.

Qualifications

• High School Diploma or GED; additional education preferred.
• Significant experience in QC or regulated manufacturing, with exposure to investigations, audits, and CAPA.
• Strong analytical, problem-solving, and decision-making skills.
• Effective leadership, mentoring, and cross-functional collaboration.
• Proficiency in Microsoft Office and regulatory documentation.
• Ability to lift 25 lbs and perform standard physical duties.
• Excellent written and verbal communication skills