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Great opportunity to work for our busy and growing client in Fort Worth, TX as a Quality Assurance Associate/Technician on a direct hire basis.
Company Profile:
In business over 20 years
Develops, manufactures, markets, and sells branded prescription pharmaceutical products
Quality Assurance Associate/Technician Role:
The Quality Assurance Associate/Technician will be a highly visible part of the Quality Assurance Team and will work in compliance with the current good manufacturing practice regulations, procedures and specifications.
Responsible for performing in-process inspections
Responsible for batch record review and quality system functions
Responsible to work in accordance with current good manufacturing practice regulations, and state, federal and local laws where applicable, safety and FDA regulations
Will monitor, perform and document sampling/testing and inspection of raw material/components and document the results
As needed, will review completed batch records and dispositions raw materials and components
For the cleaning validation studies, you will collect rinse samples and oversee the swab sampling
Collect samples at various stages in process validation studies
Performs in-process inspections accurately
Responsible for accurate documentation of all activities on appropriate forms or in the batch record
Responsible for reviewing completed batch records and issuing batch records and associated forms to production
Maintains quarantine/release/reject system for raw materials, labeling materials, and finished drug products
Responsible for maintaining a neat, clean, safe and organized work area
Responsible to notify appropriate team members if there are any variants to process, material, or nonconforming incidents
Perform cleaning validation sampling
Assist in conducting investigations of process deviations
Notify production quickly of any problems with in-process testing results
Will be responsible for assisting the line leads and supervisor with performing training, specifically work instructions, for new staff, less seasoned staff
Quality Assurance Associate/Technician Background Profile:
The Quality Assurance Associate/Technician will have a Bachelor’ s degree
1+ years’ experience in a cGMP/Pharmaceutical environment
In lieu of a Bachelor’ s degree, candidate would have an Associates degree with 3+ years of experience in a cGMP/Pharmaceutical environment
2+ years’ hands on experience doing the essential duties of the position as outlined above
Ability to be flexible with schedule – some extended hours and weekend work is to be expected
Skilled understanding of performing standardized tests/operations and how to operate and adjust varied equipment
Knowledge of basic or commonly used rules, procedures and regulations
Excellent communication skills
Ability to obtain, clarify and give factual information
Ability to interpret instructions, record data clearly and have a high degree of precision and accuracy
Able to communicate effectively with colleagues on varied levels
Strong/intermediate level and proficiency with MS Office Suite
Taking situational and regulatory compliance into context, have the ability to apply independent judgement regarding what needs to be done and next steps
Using available information and documentation, have the ability to recognize the existence of and differences among varied situations
Features and Benefits:
Opportunity to participate in a great benefits package!
Disclaimer: sensitive and personal data will not be requested by Frontline Source Group or its affiliates until a job offer is made and accepted. If you ever doubt the validity of our job postings, we encourage you to call one of our branch locations to verify the status on any job.
