Arcaea, LLC
Quality Assurance Specialist (Part-time) Boston, MA
Arcaea, LLC, Boston, Massachusetts, us, 02298
Quality Assurance Specialist (Part-time)
Arcaeais a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology.Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of delivering radical performance and unparalleled sustainability that will also present new opportunities for storytelling.Arcaea is seeking an experienced Quality Assurance Specialist to join our team and play a critical role in developing our ingredient toolset for the beauty and personal care industry. As a member of the Arcaea team, you will be responsible for leading Arcaea's QA/QC efforts.No candidate will meet every single desired qualification. If your experience looks a little different from what we’ve identified and you think you can bring value to the role, we’d love to learn more about you!WHAT YOU WILL DO:Author, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, QC and supply chainDevelop a Quality program including the implementation of a Quality Management SystemOversee all QA/QC activities at Contract Manufacturing organizations (CMO) and Contract testing laboratoriesBatch Record Review: Review and analyze batch records for adherence to Good Manufacturing Practices (GMP) and internal quality standardsCompliance Monitoring: Collaborate with cross-functional teams to monitor compliance with regulatory requirements and company policiesReview and approval of deviations / non-conformances and lead the strategic discussion for out of specification investigations with respect to operations or validation/qualification related mattersImplement audit program and manage auditsDocumentation: Maintain accurate and detailed documentation related to quality assurance activitiesCreate and/or review and enforce Quality Agreements with CMO partnersDevelop and manage the QA/QC budgetsEnsure QC work (analytical and non-analytical) meets quality and timing expectations to support operationsRepresent the company with government agencies, vendors, and customersSupport regulatory efforts for the company in all product linesCommunicate QA & QC goals and progress with executive management and external partners as neededProvide strategic input to Product Development, Manufacturing, and Platform Development initiatives to align with quality plans and budgetsManage 3rd party testing laboratories including sample logisticsWHAT WE SEEK:BS/ in Biology, Microbiology, Chemistry, or equivalent experience5+ years of experience in quality assuranceA working knowledge of 21 CFR 710 FDA regulationsAbility to communicate at all levels of the organization and apprise senior management of critical issuesFamiliarity with Good Manufacturing Practices (GMP) and their application in the biotech sectorFamiliarity with batch records and their significance in maintaining product qualityAttention to Detail: Strong attention to detail and commitment to maintaining high-quality standardsStartup experience preferredWe feel that it’s important to point out the obvious here – there’s a serious lack of diversity in both the scientific fields and beauty industry, and that needs to change. Our goal is to help drive that change. We are deeply committed to diversity, equality, and inclusion in all its practices, especially when it comes to growing our team. Our culture promotes inclusion and embraces how rewarding it is to work with people from all walks of life.No candidate will meet every single desired qualification. If your experience looks a little different from what we’ve identified and you think you can bring value to the role, we’d love to learn more about you!We’re working with the powerful biological engineering platform at Ginkgo Bioworks, so we must remain mindful of the many ways our technology can – and will – impact people around the world. Ginkgo and Arcaea care about how this platform and the products created are used. Having a diverse team to build it gives us the best chance that it’s something we’ll be proud of as it continues to grow. Therefore, it’s critical that we incorporate the diverse voices and visions of all those who play a role in the future of biology in every industry.We are committed to diversity, equality, and inclusion in all its practices. It is the policy of Arcaea to provide equal employment opportunities to all employees and employment applicants.Agency and Third Party Recruiter Notice: Agencies that submit a resume to Arcaea must have a current executed Arcaea Agency Agreement executed by the Director, People Operations. In addition Agencies may only submit candidates to positions for which they have been invited to do so by an Arcaea Recruiter. All resumes must be sent to the Arcaea Recruiter under these terms or they will not be considered.If you have a disability under the Americans with Disabilities Act or similar law, or you require religious accommodation, and you wish to discuss potential accommodations related to applying for employment at our company, please contact recruiting@arcaea.com
.Arcaea participates in E-verify to determine employment eligibility.Disclaimer: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.Accepted file types: pdf, doc, docx, txt, rtfAccepted file types: pdf, doc, docx, txt, rtfLinkedIn ProfileWebsiteVoluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.As set forth in Arcaea’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.Select...Voluntary Self-Identification of Disability
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We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to:Alcohol or other substance use disorder (not currently using drugs illegally)Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDSBlind or low visionCancer (past or present)Cardiovascular or heart diseaseCeliac diseaseCerebral palsyDeaf or serious difficulty hearingDiabetesDisfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disordersEpilepsy or other seizure disorderGastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndromeIntellectual or developmental disabilityMental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSDMissing limbs or partially missing limbsMobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supportsNervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilitiesPartial or complete paralysis (any cause)Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysemaShort stature (dwarfism)Traumatic brain injury
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Arcaeais a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology.Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of delivering radical performance and unparalleled sustainability that will also present new opportunities for storytelling.Arcaea is seeking an experienced Quality Assurance Specialist to join our team and play a critical role in developing our ingredient toolset for the beauty and personal care industry. As a member of the Arcaea team, you will be responsible for leading Arcaea's QA/QC efforts.No candidate will meet every single desired qualification. If your experience looks a little different from what we’ve identified and you think you can bring value to the role, we’d love to learn more about you!WHAT YOU WILL DO:Author, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, QC and supply chainDevelop a Quality program including the implementation of a Quality Management SystemOversee all QA/QC activities at Contract Manufacturing organizations (CMO) and Contract testing laboratoriesBatch Record Review: Review and analyze batch records for adherence to Good Manufacturing Practices (GMP) and internal quality standardsCompliance Monitoring: Collaborate with cross-functional teams to monitor compliance with regulatory requirements and company policiesReview and approval of deviations / non-conformances and lead the strategic discussion for out of specification investigations with respect to operations or validation/qualification related mattersImplement audit program and manage auditsDocumentation: Maintain accurate and detailed documentation related to quality assurance activitiesCreate and/or review and enforce Quality Agreements with CMO partnersDevelop and manage the QA/QC budgetsEnsure QC work (analytical and non-analytical) meets quality and timing expectations to support operationsRepresent the company with government agencies, vendors, and customersSupport regulatory efforts for the company in all product linesCommunicate QA & QC goals and progress with executive management and external partners as neededProvide strategic input to Product Development, Manufacturing, and Platform Development initiatives to align with quality plans and budgetsManage 3rd party testing laboratories including sample logisticsWHAT WE SEEK:BS/ in Biology, Microbiology, Chemistry, or equivalent experience5+ years of experience in quality assuranceA working knowledge of 21 CFR 710 FDA regulationsAbility to communicate at all levels of the organization and apprise senior management of critical issuesFamiliarity with Good Manufacturing Practices (GMP) and their application in the biotech sectorFamiliarity with batch records and their significance in maintaining product qualityAttention to Detail: Strong attention to detail and commitment to maintaining high-quality standardsStartup experience preferredWe feel that it’s important to point out the obvious here – there’s a serious lack of diversity in both the scientific fields and beauty industry, and that needs to change. Our goal is to help drive that change. We are deeply committed to diversity, equality, and inclusion in all its practices, especially when it comes to growing our team. Our culture promotes inclusion and embraces how rewarding it is to work with people from all walks of life.No candidate will meet every single desired qualification. If your experience looks a little different from what we’ve identified and you think you can bring value to the role, we’d love to learn more about you!We’re working with the powerful biological engineering platform at Ginkgo Bioworks, so we must remain mindful of the many ways our technology can – and will – impact people around the world. Ginkgo and Arcaea care about how this platform and the products created are used. Having a diverse team to build it gives us the best chance that it’s something we’ll be proud of as it continues to grow. Therefore, it’s critical that we incorporate the diverse voices and visions of all those who play a role in the future of biology in every industry.We are committed to diversity, equality, and inclusion in all its practices. It is the policy of Arcaea to provide equal employment opportunities to all employees and employment applicants.Agency and Third Party Recruiter Notice: Agencies that submit a resume to Arcaea must have a current executed Arcaea Agency Agreement executed by the Director, People Operations. In addition Agencies may only submit candidates to positions for which they have been invited to do so by an Arcaea Recruiter. All resumes must be sent to the Arcaea Recruiter under these terms or they will not be considered.If you have a disability under the Americans with Disabilities Act or similar law, or you require religious accommodation, and you wish to discuss potential accommodations related to applying for employment at our company, please contact recruiting@arcaea.com
.Arcaea participates in E-verify to determine employment eligibility.Disclaimer: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.Accepted file types: pdf, doc, docx, txt, rtfAccepted file types: pdf, doc, docx, txt, rtfLinkedIn ProfileWebsiteVoluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.As set forth in Arcaea’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.Select...Voluntary Self-Identification of Disability
Form CC-305Page 1 of 1OMB Control Number 1250-0005Expires 04/30/2026Voluntary Self-Identification of Disability
Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to:Alcohol or other substance use disorder (not currently using drugs illegally)Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDSBlind or low visionCancer (past or present)Cardiovascular or heart diseaseCeliac diseaseCerebral palsyDeaf or serious difficulty hearingDiabetesDisfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disordersEpilepsy or other seizure disorderGastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndromeIntellectual or developmental disabilityMental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSDMissing limbs or partially missing limbsMobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supportsNervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilitiesPartial or complete paralysis (any cause)Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysemaShort stature (dwarfism)Traumatic brain injury
Disability Status
Select...
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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