QA Compliance Specialist II (Investigations)
DescriptionWe believe being healthy should not require tradeoffs.
SCN BestCo is a leading innovator, developer and manufacturer of Vitamin, Mineral & Supplement (VMS), Over-the-Counter (OTC) and prebiotics/probiotics in enjoyable forms such as gummies, lozenges and chews.
With over 50 years of excellence, our team leads the way in changing how consumers make healthier choices.
With unique food science expertise and proprietary processes, we've pioneered many firsts.
Our passion to create new to the world products has guided and continues to be core to our mission of making health and wellness more enjoyable.
Come join us and become a part of our winning formula! Essential Duties and
Responsibilities:
Completion of advanced level manufacturing investigations (Primary Function).
Independently investigate and write quality incident investigations, including more complex events.
Level II investigations include but are not limited to:
Out of Specification (OOS) laboratory results of in-process, finished product, and/or stability samplesProduct formulation associated deviations requiring multistage process traceability to determine impact scopeOOS total Microbial Count deviationsEvents related to mechanical equipment failure with potential breakdown of metal componentsComplete work efficiently within established timelines to ensure regulatory compliance and in accordance with company goals.
Proactively collaborate with departmental management to identify, document, and implement effective corrective actions.
Supports the evaluation and verification of task effectiveness in addressing the root cause of quality incidents.
As part of investigation process, interview department personnel and review procedures, as well as manufacturing and training records.
Draft and support the execution of training plans related to quality incidents involving SOPs (Standard Operating Procedures), job aides, one-point lessons, etc.
Perform complex product traceability activities to assess product impact and determine product disposition.
Lead groups in Root Cause Analysis as required.
Supports integrity and accuracy in all facets of the organization.
Establish a working relationship with contract customers.
Use of electronic documentation systems/software:
Master Control:
Initiation, completion, and routing processes for manufacturing investigations.
Initiation and completion of corrective action tasks and effectiveness checks.
Initiation and completion of document updates and change controls and scrap tickets.
SAP:
Tracking and traceability of inventory in support of manufacturing investigations.
Microsoft Office / Windows (Excel, Word, Teams, Outlook)Use of Outlook and Teams Software to communicate electronically within the workplace as well as with outside vendors / customers.
Use MicroSoft Word software to document investigation drafts and other supporting documentation as required.
Use Excel daily to document status of investigations, metrics, and other supporting initiatives.
Participate in weekly Gemba and other planning meetings as required.
Provide support for internal, external, customer audits and regulatory inspections.
Performs other duties as assigned.
Travel - Less than 10%.
Occasional travel for offsite audits and/or training may be required.
Required
Qualifications:
Education/
Experience:
Bachelor's degree in engineering or science and at least 3 years of experience in a cGMP manufacturing facility or an associate degree and at least 5 years of experience in a cGMP manufacturing facility or a High School Diploma/GED and 7 years of experience in a cGMP manufacturing facility writing highly detailed quality investigations related to manufacturing processes.
A minimum of two years of demonstrated experience drafting technical documents in a cGMP Manufacturing or Quality department, preferably quality incident investigations.
Demonstrated working knowledge of cGMP regulation and application within food and/or pharmaceutical manufacturing operations.
Knowledge, Skills, & Abilities (KSAs) Required:
Proficiency in Microsoft Office software programs required.
Ambitious, confident, critical thinking, self-starter with the ability to work under pressure with a sense of urgency in a fast-paced environment required.
Ability to effectively communicate, verbally and written, with internal staff, management, and customers.
Ability to speak effectively before groups of customers or employees of the organization.
Ability to complete work independently.
Ability to work on project teams and oversee multiple projects simultaneously.
Demonstrated proficiency completing root cause analysis.
Demonstrated proficiency in developing and implementing effective corrective actions and assessing the effectiveness of those actions.
Demonstrated practical problem solving and trouble shooting skillsPreferred
Qualifications:
Three years of working experience in investigating and writing quality incident investigations, to include identification of corrective and preventive actions to address root cause analysis and mitigation.
Prior work experience supporting audit processes.
Thorough knowledge of common manufacturing processes and equipment mechanical function.
Prior background in QC Analytical lab processes, either working in a lab or performing investigations related to lab activities.
Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR 60-1.
35(c) Recommended Skills Auditing Communication Confident And Emotionally Stable Critical Thinking Foods Hardworking And Dedicated Estimated Salary: $20 to $28 per hour based on qualifications.
SCN BestCo is a leading innovator, developer and manufacturer of Vitamin, Mineral & Supplement (VMS), Over-the-Counter (OTC) and prebiotics/probiotics in enjoyable forms such as gummies, lozenges and chews.
With over 50 years of excellence, our team leads the way in changing how consumers make healthier choices.
With unique food science expertise and proprietary processes, we've pioneered many firsts.
Our passion to create new to the world products has guided and continues to be core to our mission of making health and wellness more enjoyable.
Come join us and become a part of our winning formula! Essential Duties and
Responsibilities:
Completion of advanced level manufacturing investigations (Primary Function).
Independently investigate and write quality incident investigations, including more complex events.
Level II investigations include but are not limited to:
Out of Specification (OOS) laboratory results of in-process, finished product, and/or stability samplesProduct formulation associated deviations requiring multistage process traceability to determine impact scopeOOS total Microbial Count deviationsEvents related to mechanical equipment failure with potential breakdown of metal componentsComplete work efficiently within established timelines to ensure regulatory compliance and in accordance with company goals.
Proactively collaborate with departmental management to identify, document, and implement effective corrective actions.
Supports the evaluation and verification of task effectiveness in addressing the root cause of quality incidents.
As part of investigation process, interview department personnel and review procedures, as well as manufacturing and training records.
Draft and support the execution of training plans related to quality incidents involving SOPs (Standard Operating Procedures), job aides, one-point lessons, etc.
Perform complex product traceability activities to assess product impact and determine product disposition.
Lead groups in Root Cause Analysis as required.
Supports integrity and accuracy in all facets of the organization.
Establish a working relationship with contract customers.
Use of electronic documentation systems/software:
Master Control:
Initiation, completion, and routing processes for manufacturing investigations.
Initiation and completion of corrective action tasks and effectiveness checks.
Initiation and completion of document updates and change controls and scrap tickets.
SAP:
Tracking and traceability of inventory in support of manufacturing investigations.
Microsoft Office / Windows (Excel, Word, Teams, Outlook)Use of Outlook and Teams Software to communicate electronically within the workplace as well as with outside vendors / customers.
Use MicroSoft Word software to document investigation drafts and other supporting documentation as required.
Use Excel daily to document status of investigations, metrics, and other supporting initiatives.
Participate in weekly Gemba and other planning meetings as required.
Provide support for internal, external, customer audits and regulatory inspections.
Performs other duties as assigned.
Travel - Less than 10%.
Occasional travel for offsite audits and/or training may be required.
Required
Qualifications:
Education/
Experience:
Bachelor's degree in engineering or science and at least 3 years of experience in a cGMP manufacturing facility or an associate degree and at least 5 years of experience in a cGMP manufacturing facility or a High School Diploma/GED and 7 years of experience in a cGMP manufacturing facility writing highly detailed quality investigations related to manufacturing processes.
A minimum of two years of demonstrated experience drafting technical documents in a cGMP Manufacturing or Quality department, preferably quality incident investigations.
Demonstrated working knowledge of cGMP regulation and application within food and/or pharmaceutical manufacturing operations.
Knowledge, Skills, & Abilities (KSAs) Required:
Proficiency in Microsoft Office software programs required.
Ambitious, confident, critical thinking, self-starter with the ability to work under pressure with a sense of urgency in a fast-paced environment required.
Ability to effectively communicate, verbally and written, with internal staff, management, and customers.
Ability to speak effectively before groups of customers or employees of the organization.
Ability to complete work independently.
Ability to work on project teams and oversee multiple projects simultaneously.
Demonstrated proficiency completing root cause analysis.
Demonstrated proficiency in developing and implementing effective corrective actions and assessing the effectiveness of those actions.
Demonstrated practical problem solving and trouble shooting skillsPreferred
Qualifications:
Three years of working experience in investigating and writing quality incident investigations, to include identification of corrective and preventive actions to address root cause analysis and mitigation.
Prior work experience supporting audit processes.
Thorough knowledge of common manufacturing processes and equipment mechanical function.
Prior background in QC Analytical lab processes, either working in a lab or performing investigations related to lab activities.
Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR 60-1.
35(c) Recommended Skills Auditing Communication Confident And Emotionally Stable Critical Thinking Foods Hardworking And Dedicated Estimated Salary: $20 to $28 per hour based on qualifications.
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