Associate Quality Assurance NS
Description:
Duration: 12 months
Swing shift - 12-hour shifts - Must have flexibility with shifts
10 PM - 6:30 AM - may fluctuate over the duration of the contract
Job Description:
Ideal Candidate: B.S or relevant experience. A GMP background is nice to have.Nice to have: Veeva, Trackwise, SAP, Maximo, and MES.
Primary responsibilities of this position include inspecting raw materials, components, and labels, in addition to sampling raw materials, labels, and sanitary utilities, and generating/compiling quality data and reports (e.g., lot track/trace, incidents). Will also assist with document review and initiate incidents, as well as coordinate and compile general documents, and oversee room clearance inspection.; Skills: quality assurance or manufacturing experience in the pharmaceutical or medical device industry
Key Responsibilities:
Provide daily guidance and support to manufacturing staff regarding compliance with Standard Operating Procedures and Work Instructions.
Ensure regular presence in the packaging area to provide oversight to GMP operations and quality systems.Act as a first point of contact in case of production staff inquiries (quality-related) during operations.
Review and approve batch record documentation, assist in sampling and inspections as required, and other GMP documentation in support of daily operations.
Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions, and Forms.
Review and approve minor deviations.
Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting Environmental Health and Safety corporate and site goals.
Top 3 must-have skills:
Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
Experience in and knowledge of GMP/GCP operations or similarly regulated industry
Highly effective verbal and written communication skills, strong interpersonal skills
Great attention to detail and a high degree of accuracy in task execution and GMP documentation
Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.
Strong organizational skills, including the ability to follow assignments through to completion.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ( .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.