Quality Control Technician

Job Description

Job Description

JOB SUMMARY

The Quality Control Technician will work as part of the Quality Unit, alongside manufacturing operations, participating in activities such as verifying input processes, conducting internal audits, performing in-process testing, and reviewing completed lab documentation.

KEY RESPONSIBILITIES

• Represents the Quality Unit during manufacturing operations, acting as the “customer on site” and ensuring local, state, and federal regulations are being followed
• Follows regulatory, cGMP, and USP guidelines as required by job function
• Works alongside manufacturing operations, verifying procedures, reviewing documentation, etc.
• Performs regularly scheduled walk-throughs in the production areas such as formulation, sample/pre-weigh, and the filling room (production areas), as well as the Warehouse
• Performs AQL visual inspection of finished good products
• Performs Environmental Monitoring of Class C production areas, including sample collection
• Reviews line clearance and setup in production areas prior to the start of a new batch or operation
• Provides Quality approval and acceptance, including the release of raw materials, components, and finished products/preparations
• Performs packaging and product label reviews, cleaning and maintenance log reviews, and assists with quality investigations
• Collects retention sample and monitors drug storage requirements
• Follows and trains others to comply with the company’s standard operating procedures (SOPs)
• Completes other projects and duties as required and/or necessary

EDUCATION / TRAINING

• High School Diploma or GED from recognized institution or organization required
• Associates degree in scientific discipline or closely related technical field of study preferred
• Certified Pharmacy Technician preferable

WORK EXPERIENCE

• Minimum of 2-years of pharmaceutical experience in a pharmaceutical company or quality role
• Quality-driven, results oriented, and strong attention to detail
• Proven organizational and time management skills
• Aptitude for decision-making and performing risk assessments
• Good computer skills with basic knowledge of Microsoft based programs

ADDITIONAL QUALIFICATIONS (OPTIONAL)

• Ability to work independently with little to no supervision
• Strong communication skills
• Proactive and hands-on