Quality Control Specialist

Job Summary:

The Quality Control Specialist is a critical member of the team, ensuring the production and distribution of high-quality, sterile pharmaceutical products in compliance with FDA regulations, cGMP guidelines, and USP standards. This role involves conducting rigorous testing, inspections, and documentation throughout the manufacturing process to verify product integrity, sterility, and accuracy.

Key responsibilities include performing laboratory analyses, environmental monitoring, and equipment calibration; reviewing and maintaining quality control records; and collaborating with cross-functional teams to identify and address quality issues. The specialist must remain updated on regulatory changes and implement continuous improvement initiatives to enhance operational quality and efficiency.

Duties/Responsibilities:

Works effectively and efficiently in a team environment.

Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility, as needed

Incubation and enumeration of samples related to environmental monitoring processes, as needed.

Conduct morphology assessment on appropriate samples at the conclusion of the incubation term, as needed.

Perform review and release of raw materials, API, and excipients.

Coordinates third party sample submission.

Demonstrates the ability to perform detail-oriented work with a high degree of accuracy.

Conduct investigations pertaining to OOS/OOT of raw materials, in-process, and finished product results with production personnel and/or supplier.

Assists with all aspects of the quality system, such as change control, investigations, CAPA, and validation systems to ensure compliance and timely completion of assigned activities.

Compiling data for quarterly report review.

Review and release of finished product testing results.

Generation of Certificate of Analysis and Finished Good Forms for batch release.

Participate in product development meetings and represent Quality Control.

Assist with the development, management and improvement of quality system processes and procedures to ensure compliance with applicable laws, regulations, and company standards in support of cGMP for pharmaceutical compounding.

Lead/support audits (internal and external) to ensure compliance to CGMP regulations and internal procedures.

Performs other duties as assigned.

Required Skills/Abilities:

Excellent verbal and written communication skills.

Excellent interpersonal and customer service skills.

Excellent sales and customer service skills.

Excellent organizational skills and attention to detail.

Excellent time management skills with a proven ability to meet deadlines.

Strong analytical and problem-solving skills.

Strong supervisory and leadership skills.

Ability to prioritize tasks and to delegate them when appropriate.

Ability to function well in a high-paced and at times stressful environment.

Proficient with Microsoft Office Suite or related software.

Education and Experience:

BS/BA in Microbiology, Chemistry, or a relevant field/or equivalent experience.

2-5 years of Quality Control experience.

Experience in a cGMP environment.

Previous pharmaceutical experience.

Familiarity with 21 CFR Part 11/210/211.

Experience with aseptic manufacturing environments.

Comfortable in a fast-paced, small company environment and able to adjust workload based upon changing priorities.

Physical Requirements:

Demonstrates ability to walk and stand for prolonged periods of time.

Demonstrates ability to sit/ stand at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.