QA Product Associate
- Location: Fort Worth
- Type: Contract To Hire
- Job #36566
Exciting new opportunity with a leading pharmaceutical company for a 6 month contract to hire assignment!
Local to Fort Worth as a Contract to Hire opportunity, the Quality Assurance Product Associate is responsible for the review documented results of Quality Control testing and chose disposition (i.e. release or reject) for incoming raw materials, components, and labeling, in-process materials, and finished product for the next stage of production or distribution. A successful QA Product Associate will be strong Microsoft Word & Excel, has previous GMP, Batch Record Review, Labeling Investigations, and CAPA experience.
Essential functions of the job include but are not limited to:
- Review documented results of Quality Control testing and chose disposition (i.e. release or reject) for incoming raw materials, components, and labeling, in-process materials, and finished product for the next stage of production or distribution, as appropriate, as well as review documentation in accordance with Good Documentation Practices and provide verification of activities performed by Production and Quality Control personnel.
- Provide quality support during the production processes including, but not limited to, room and/or equipment release, verification of calculations in batch records, comparison of approved labeling required versus labeling released to room, in-process quality checks, and providing stability and retain samples to Quality Control as necessary.
- Review primary documentation to include, but not limited to, specifications, certificates of analysis, and/or technical data sheets for raw materials, packaging components, and or labeling, research current and historical production batch records and associated stability data, as necessary, interview production personnel, examine production rooms, and perform other investigative activities to both identify root causes and find solutions to resolve them.
- CAPA and Change Control, prepare Corrective and Preventive Action Plans with itemized actions to verify that the proposed CAPA do not negatively impact current quality measures, ensure the boundaries of the actions include all products and/or lots with the same issue, and that the measures to be taken address root cause(s) identified in corresponding investigations.
- Prepare and edit Change Requests to ensure that the measures to be taken have addressed all related
- Manage Change Requests to confirm deliverables have been met before closing. Upon completion of changes, follow up to ensure CAPA was effective at resolving root cause(s) before closing the CAPA.
- Labeling Control by reviewing labeling to ensure that the ingredients list and facts box correspond to the formulation, that all the applicable state and federal regulations are complied with, and/or that the physical properties conform to current packaging line capabilities, as necessary.
- Assist with ensuring that labeling is segregated from non-labeling components, inventory counts, and processing of labeling to and from packaging lines. Upload labeling as required by state and/or federal agencies.
- High School Diploma required.
- Possesses a basic knowledge of theories, practices, and procedures in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems.
- cGMP and ISO 9001 experience
- Strong MS Office Suite Experience (Word, Excel, PowerPoint, Outlook)
**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**