Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
true
Target PR Range: 19-27/hr
*Depending on experience
·                 In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
·                 Compile, verify, and review Device History Records to ensure accuracy and completeness per procedures. Separate into loads for release purposes.
·                 Perform pre-sterile and post-sterile inspection of products according to procedure as appropriate.
·                 Inspect and release raw materials, components, sub-assemblies (ex Crescent Bodies), and finished devices according to procedure.  Will be focused on sub-assembly and final release of finished devices in the clean room.Â
·                 Includes sending bioburden and LAL samples to supplier
·                 Document Non-Conforming Reports as needed and participate in investigations.
·                 Audit In-process records, receiving inspection documentation, final inspection documentation, and other quality or manufacturing data for accuracy and completeness. Includes internal audits.
·                 Complete first article inspections.
·                 Ability to use many types of precision measuring equipment, such as calipers, height gages, viscometers, optical comparator, CMM, and others
·                 Collaborate with engineering and machine shop staff on the design of measurement gages and holding fixtures.
·                 Assist Product Engineering Department in the evaluation of prototype components.
·                 Must be capable of communicating with suppliers on dimensional characteristics which are showing trends of instability.Â
·                 Execute gage R&R studies on measurement instruments and CMM holding fixtures.
·                 May be responsible to manage and administer the calibration program for all tools requiring calibration.
·                 Maintain and update Quality system documentation, such as work instructions, procedures, in-process inspection information, and other related documentation.
·                 Internal auditor
·                 Perform other duties as assigned.Â
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Education Required:Â High school diploma
Years’ Experience Required: 2?
Â
Will the contractor be working 40 hours a week?  Yes If not, weekly estimate?
Work Location: Dexter MI Site – must be on site
               Do they need to be local to any MDT office and if so where?
Does this person need to be on site? If so, full time or part time?
Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Reviews production records for conformance to procedures. Conducts non-conformance tests of manufactured, packaged or tested product. TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes. DIFFERENTIATING FACTORS: Autonomy: Established and productive individual contributor, working under moderate supervision. Performs tests, interprets data and develops reports. Organizational Impact: Performs intermediate technical activities requiring judgment and decision-making. Work consists of technical tasks that are typically routine. Innovation and Complexity: Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems. May be required to highlight areas of concerns/problems in own job area. Communication and Influence: Communicates typically with internal contacts. Obtains and provides technical information requiring some explanation or interpretation. Leadership and Talent Management: May provide guidance and assistance to new or entry level employees. Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.
Quality Technician II - Non-Exempt
2555 Bishop Circle West Dexter, MI 48130 US
Posted: 10/07/2024
2024-10-07
2024-11-13
Employment Type:
Contract
Job Category: Quality and Compliance
Job Number: 614532
Is job remote?: No
Country: United States
Job Description
Target PR Range: 19-27/hr
*Depending on experience
·                 In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
·                 Compile, verify, and review Device History Records to ensure accuracy and completeness per procedures. Separate into loads for release purposes.
·                 Perform pre-sterile and post-sterile inspection of products according to procedure as appropriate.
·                 Inspect and release raw materials, components, sub-assemblies (ex Crescent Bodies), and finished devices according to procedure.  Will be focused on sub-assembly and final release of finished devices in the clean room.Â
·                 Includes sending bioburden and LAL samples to supplier
·                 Document Non-Conforming Reports as needed and participate in investigations.
·                 Audit In-process records, receiving inspection documentation, final inspection documentation, and other quality or manufacturing data for accuracy and completeness. Includes internal audits.
·                 Complete first article inspections.
·                 Ability to use many types of precision measuring equipment, such as calipers, height gages, viscometers, optical comparator, CMM, and others
·                 Collaborate with engineering and machine shop staff on the design of measurement gages and holding fixtures.
·                 Assist Product Engineering Department in the evaluation of prototype components.
·                 Must be capable of communicating with suppliers on dimensional characteristics which are showing trends of instability.Â
·                 Execute gage R&R studies on measurement instruments and CMM holding fixtures.
·                 May be responsible to manage and administer the calibration program for all tools requiring calibration.
·                 Maintain and update Quality system documentation, such as work instructions, procedures, in-process inspection information, and other related documentation.
·                 Internal auditor
·                 Perform other duties as assigned.Â
Â
Education Required:Â High school diploma
Years’ Experience Required: 2?
Â
Will the contractor be working 40 hours a week?  Yes If not, weekly estimate?
Work Location: Dexter MI Site – must be on site
               Do they need to be local to any MDT office and if so where?
Does this person need to be on site? If so, full time or part time?
Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Reviews production records for conformance to procedures. Conducts non-conformance tests of manufactured, packaged or tested product. TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes. DIFFERENTIATING FACTORS: Autonomy: Established and productive individual contributor, working under moderate supervision. Performs tests, interprets data and develops reports. Organizational Impact: Performs intermediate technical activities requiring judgment and decision-making. Work consists of technical tasks that are typically routine. Innovation and Complexity: Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems. May be required to highlight areas of concerns/problems in own job area. Communication and Influence: Communicates typically with internal contacts. Obtains and provides technical information requiring some explanation or interpretation. Leadership and Talent Management: May provide guidance and assistance to new or entry level employees. Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.
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Discover exciting job opportunities in the vibrant town of Dexter, Michigan! Nestled in the picturesque landscape of Washtenaw County, Dexter offers a perfect blend of small-town charm and big-city amenities. With easy access to Ann Arbor's renowned art galleries and theaters, as well as the University of Michigan's sports events, this area is a hub for culture and entertainment. Explore the beauty of Hudson Mills Metropark or indulge in the local delicacies at Zingerman's Delicatessen. Join us in Dexter, where career growth meets a relaxed lifestyle, making it an ideal place to thrive both professionally and personally. Explore our job listings today and take the next step towards building your career in this enchanting region.
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
