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
Numbers & Facts
Location
Dallas, TX
Skills
Auditingunmatched
Biotech and Pharmaceuticalunmatched
Certified Pharmacy Technician (CPhT)unmatched
Communication Skillsunmatched
Computer Skillsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Detail Orientedunmatched
Documentationunmatched
Documentation Reviewunmatched
Environmental Monitoringunmatched
Federal Laws and Regulationsunmatched
High School Diplomaunmatched
Housekeeping/Cleaningunmatched
Internal Auditunmatched
Manufacturing Operationsunmatched
Microsoft Product Familyunmatched
Operations Processesunmatched
Product Reviewsunmatched
Quality Controlunmatched
Regulationsunmatched
Risk Analysisunmatched
Specimen Collectionunmatched
Standard Operating Procedures (SOP)unmatched
State Laws and Regulationsunmatched
Time Managementunmatched
Warehousingunmatched
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