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Manufacturing Associate III

Company: Aerotek
Location: West Sacramento
Posted on: April 9, 2021

Job Description:

Hiring a Manufacturing Supervisor with a great company in West Sacramento, CA! Description:The Manufacturing Associate III will work within the Manufacturing Department and be responsible for daily execution of tasks associated with the manufacture of cell culture products produced by the company in accordance with cGMPs. Their products are made aseptically and are sterile-filled following cGMPs. In addition, this person will be asked to assist, and/or perform tasks outside of direct product manufacturing, such as cleaning the manufacturing spaces or to execute maintenance, calibration or validation protocols. This person will be expected to follow, write and implement standard operating procedures (SOPs), work instructions (WIs) and device history records (DHRs) following FDA, USDA, and/or other applicable international guidance documents. This person will always be expected to collaborate as a team player with personnel in EHS, Engineering, Supply Chain, Quality Control, Quality Assurance and Information Technology to effectively perform duties of manufacturing within Gemini.Key ResponsibilitiesAbide by all safety requirements as defined by the companyRead and follow all Company SOPs and guidelinesDocument all work as required by cGMPs on a real time basisAssist with or lead Deviation investigations/closures, CAPA closures or Change ControlsWork with appropriate support groups to assess product impact of manufacturing deviations and write product impact statements as necessary.Solve technical manufacturing issues, either lead teams or be an integral member of the team.Assist with clean room sanitization as requiredPass and sustain aseptic qualifications which consist of passing gown qualification, maintaining gown access, passing Grade A qualifications, passing media fill qualifications, and perform environmental monitoring during aseptic fillingPerform aseptic production operations and validationsAssist with facility and process validations as requiredAssist with facility cleaning, operational maintenance or calibrationSkills:gmp, laboratory, capa, media fill, cgmp, FDA, USDATop Skills Details:media fill, manufacturing associate, SOP, cGMP, FDA regulated, laboratoryAdditional Skills & Qualifications:Determine and define responsibilities for each group reporting into the Sr. DirectorOversee product release through the Quality Assurance groupManage communication with outside customer/ sales repsOversee internal and external audits and responsesWork with the Regulatory group to file regulatory documents in a timely fashionEstablish and manage Quality metricsLiaise with internal and external partners to support ongoing building and equipment validation.Company ValuesConfidentAdaptableResults drivenReliableInnovativeEthicalDecisiveExperience Level:Intermediate Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, West Sacramento , Manufacturing Associate III, Other , West Sacramento, California

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