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Quality Assurance Associate

Company: Source One Technical Solutions
Location: Fort Washington
Posted on: August 7, 2022

Job Description:

Third Shift role - Sun night through Fri morning (10:00pm - 6:30am)Will train on First Shift - Mon through Fri 8:00am - 5:00pm--- The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities. The Company's management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Responsibilities: (Define key accountabilities and/or activities.) Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position:--- Ensure quality and compliance in all my actions by: All employeeso Attend GMP training on the schedule designated for my role and as appropriate for my role.o Adhere to strict compliance with procedures applicable to my role.o Exercise the highest level of integrity in the tasks that I perform.o In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.o Embrace a behavior of employee involvement and commitment to doing the job right the first time.Requirements: Education: BS /BA College Degree (Science or Technical Degree preferred) or Equivalent Experience:--- BS/BA College Degree with 2 years of related Industry Experience, with proven success in cGMP/compliance environment--- Active cGMP Interpretation and Application Experience--- Demonstrated leadership- possesses the ability to lead a team--- Strong Organizational Skills--- Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)--- Problem Solving/Investigation Experience preferred--- Expertise in Handling Multiple Priorities Physical Demands: N/A--- Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance Investigation Documentation--- Experience with Liquid Dose processing and packaging technology preferred.--- Validation Experience preferred

Keywords: Source One Technical Solutions, Philadelphia , Quality Assurance Associate, Other , Fort Washington, Pennsylvania

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