Job Title : QA Associate
Regular Hours (SHIFTS)
1. MON-FRI 6AM - 2:30PM.
2.FRI, SAT, SUN 6PM - 6AM.
3. FRI, SAT, SUN 6AM - 6PM.
Duration- 6 Months (Contract To Hire)
MAJOR DUTIES:
• 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 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
Education Requirements
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.
...Function: ChristianaCare is looking for a full-time System Safety Officer to maintain continuous readiness of the organization through... ...), mechanical/industrial equipment areas, areas under construction, and occupied office environments. Travel between facilities...
Heidelberg Materials is seeking a Ready-Mix Driver at our Alfred, NY location.If you have a valid CDL Class A or B driver's license with industrial or construction driving experience, Heidelberg Materials wants to hear from you!About the Company: Heidelberg Materials...
CDL Class A Delivery Driver (Overnight) You're already doing the work, why not get paid well while doing it? CDL-A Delivery Drivers at McLane Dothan average $85,000 per year with industry leading benefits and retirement. McLane promotes earning, learning, and living...
...Miami, and Los Angles with additional locations in the works as well. Description We are looking for an Aesthetic Patient Care Coordinator to be responsible for the management of the patient pipeline, as well as optimization of sales and patient care opportunities...
...clients you see through Headway, so that you can set the hours that work for you. Grow your caseload by providing marketing support and... ...patients in-person or remotely via telehealth while working from home. We accept the following licenses on a state by state basis:...