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Quality Control Specialist

2 months ago

Denver, United States STAQ Pharma Full time

STAQ Pharma is currently hiring for a quality control specialist to join their team for the 1st shift

Monday to Friday, 6 AM to 2:30 PM

Pay: $60-$65K/year

Quality Control Specialist is responsible for:

Ensuring compliance with cGMP requirements and company procedures.

Providing QC support throughout all departments.


Roles and Responsibilities


Responsibilities for Quality Control Specialist include:

Works effectively and efficiently in a team environment.

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.

Stability testing coordination and final report generation.

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.


Qualifications and Education Requirements

BS/BA in microbiology, chemistry, or a relevant field/or equivalent experience.

2-5 years of Quality Control experience.

Experience in a cGMP environment. Preferred Skills

Previous pharmaceutical experience.

Familiarity with 21 CFR Part 11/210/211.

Experience with aseptic manufacturing environments.

Comfortable in a fast-paced, small company