Title: QA Associate
Location: Winchester KY 40391
Duration: 6 Months
Onsite Role
SHIFT - MON-FRI - 2PM - 10:30PM - TRAINING ON 1ST SHIFT MON-FRI 6AM - 2:30PM.
I. Position Overview:
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Client SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
II. Specific Tasks, Duties and Responsibilities:
• Recommend SOP and batch record changes as needed
• Review proposed SOP revisions and provide feedback to management
• Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
• Perform room and equipment clearances per procedure following cleaning conducted by production.
• Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
• Maintain a full understanding of all Client SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
• Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
• Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
• Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
• Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
• Other assignments as needed within the scope of QA Associate training curriculum.
• Assist in investigations for deviations by supporting data gathering and root cause analysis
• Enforcement of GMP Compliance.
• Promotes team work and good communication.
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Supports customer complaint investigation by performing inspection of retains and complaint samples
III. Essential Skills and Experience:
Education or Experience: (Minimum required to perform job)
• Preferred - Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience.
• Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.
• Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.
Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
• Familiarity with basic laboratory instrumentation
• Safe work habits
• Basic math and computer skills
• Good communication skills
• Ability to follow written and verbal instructions
• Able to work with limited supervision for routine tasks
• Excellent documentation and handwriting skills
• Proficient reading and comprehension skills
• Sound decision-making, technical and problem solving skills
• Good time management skills
• Expert technical writing and problem solving skills
• Good Laboratory Practices
• Experienced with continuous improvement techniques
• Demonstrates initiative
...Hello, guys! General Logistics Carrier is seeking reliable Owner-operator truck drivers to join our team! Weve delivered a great amount of loads all over the US and looking forward to delivering many more. We don't work with rental or leased vehicles. Basic Requirements...
AI Linguist Overview: We leverage large volumes of data and state-of-the-art machine learning techniques to understand what our 1B members read and write about on linkedin.com. AI Engineers and AI Linguists work together to impact positively on the LinkedIn feed ...
...or assistant project manager. Candidates require a minimum of three years of either design or construction experience on airport or airline lounge projects. Knowledge of food service equipment, bar equipment, custom millwork, stone, FFE, and operational requirements is...
...maintained at all times. Complete reports on recovered theft and fire assignments. Participate in team meetings Participate in catastrophic claim handling when requested. This may include overnight travel for extended periods of time. Adhere to privacy guidelines...
...Homes takes pride in designing homes that reflect the unique lifestyles and needs of every homeowner. The company emphasizes superior... ...Description This is a full-time on-site position for a Marketing Manager based in Dallas, TX. The Marketing Manager will oversee and...