Sr. Quality Assurance Associate
Avion Pharmaceuticals
Third Party Quality Senior Associate Job Description
The Third Party Quality Senior Associate will be responsible for the review and disposition of batch record documentation for Alora distributed products manufactured by external third parties in accordance with site SOP and regulatory guidance. The position will also perform the quality review of related cGMP documentation for Alora distributed products, including annual product reviews, and will assist with the coordination of global change controls. Key Responsibilities/Essential Functions
The Third Party Quality Senior Associate will be responsible for the review and disposition of batch record documentation for Alora distributed products manufactured by external third parties in accordance with site SOP and regulatory guidance. The position will also perform the quality review of related cGMP documentation for Alora distributed products, including annual product reviews, and will assist with the coordination of global change controls. Key Responsibilities/Essential Functions
- Critically review and disposition batch record documentation for products manufactured by external third parties.
- Perform the quality review of related cGMP documentation generated at third parties including, but not limited to deviations, out-of-specification investigations, change controls, process validation protocols/reports, and master batch records.
- Assign and/or approve lot numbers and expiration dates for products transferred to packaging facilities, as required.
- Review annual product reviews generated by third party vendors. Collect, review, and report product data needed to supplement third-party vendor annual product reviews.
- Collect and review the changes to USP and initiate any associated change controls related to those changes. Assist with the execution of a corporate USP change management system.
- Monitor and assist with the implementation of new corporate policies.
- Collect and review the changes to regulatory policies and assist in the implementation of these policies.
- Review and approve product labeling.
- Escalate issues to Quality Management, as appropriate, including, but not limited to, product quality, safety, or efficacy concerns identified in annual product reviews and critical issues identified as part of batch record review and related records.
- Track closure of assigned Third Party Quality records.
- Monitor due dates for submission of annual product reviews and perform follow-up activities.
- Assist with the generation of quality system metrics and trending reports.
- Assist with the performance of high-risk or global risk assessment impacting Alora manufactured and/or distributed products.
- Assist with the development and maintenance of procedures that define the cGMP activities within the areas of responsibility.
- Provide training and guidance to more junior Associates within the Third Party Quality team.
- Champion quality improvement processes within the areas of responsibility to ensure adherence to cGMPs and foster continuous improvement.
- Support a culture of quality and continuous improvement throughout the organization.
- Perform additional duties and responsibilities as assigned by Quality Management.
- A Bachelor's degree preferred and/or 4 years of related work experience.
- Minimum of 2 years of quality experience in FDA regulated industries (pharmaceutical or biotech industries, preferred).
- Thorough knowledge of FDA Quality System requirements.
- Ability to work independently when guided by documented procedures.
- Able to work effectively as part of a team.
- Excellent attention to detail.
- Ability to deliver within established timelines.
- Fluency in English and excellent comprehension.
- Strong oral and written communication skills.
- Proficient with Microsoft office applications.
Vacancy posted 16 hours ago
Similar jobs that could be interesting for youBased on the Sr. Quality Assurance Associate in Alpharetta, GA vacancy
- ...Quality Assurance Associate Job Description The Quality Assurance Associate will assist in completing the day‑to‑day responsibilities of the various area managers to which they report. Quality Assurance Associates may be assigned to the Senior Quality Assurance Manager...SeniorContract workWork at office
Avion Pharmaceuticals
Alpharetta, GA3 days ago - ...data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Position: Quality Assurance Specialist Position Type: 5 days Onsite Exempt Position Key Responsibilities Support the Quality Management System (QMS) in accordance...SuggestedFlexible hours
CorDx
Alpharetta, GA2 days ago - ...Are you passionate about quality, data accuracy, and helping shape the future of AI? We’re looking for a QA Ambassador who thrives on detail, consistency, and improvement. In this role, you’ll be the go-to expert for quality guidelines and content standards—ensuring our...SuggestedPermanent employmentWork at officeRemote workWork visaMonday to FridayFlexible hoursShift work
Journeyfront
Alpharetta, GA2 days ago - ...Quality Assurance Specialist Ready to put your skills as a reliable, detail-oriented professional to use and grow in your career? We're hiring quality assurance specialists and technicians right now. What's in it for you? A consistent schedule. Opportunities to grow...SuggestedImmediate start
Randstad
Peachtree Corners, GA4 days ago - ...Sr. Business Systems Analyst Onsite role in Alpharetta GA (Local) onsite interview 6 months contract Our client is hiring a Sr. Business Systems Analyst with Customs Brokerage experience. Required: ~ Expertise in Customs...SeniorContract workLocal area
3B Staffing LLC
Alpharetta, GA4 days ago - Senior Manager, Channel Marketing The Senior Manager, Channel Marketing is responsible for driving growth through our wholesale partner ecosystem. In this role, you'll develop and execute marketing strategies to support our channel partners, increase brand awareness, and...Senior
Integra Staffing and Search
Roswell, GA4 days ago - Work closely with DevOps and cloud infrastructure architects and engineers to design, implement and manage secure, scalable and reliable cloud infrastructure environments for Foghorn customers. Propose and implement cloud infrastructure transformation and automation based...Senior
Procyon TS
Alpharetta, GA4 days ago - ...industry standards. This role involves collaborating closely with cross-functional teams including civil/structural, electrical, quality assurance, and project management to ensure seamless integration of mechanical designs into final products. The engineer will be...Senior
Arseal Technologies LLC
Alpharetta, GAmore than 2 months ago - ...Job Title: Sr Salesforce Developer Location :Alpharetta, GA Duration: Long Term Only locals with 10+ Years(Inperson Interview) • 10+ year of Genuine Salesforce Development Experience !!!! • Local Candidates only • LWC • APEX • Flows...SeniorLocal area
Concord IT Systems
Alpharetta, GA2 days ago - ...Support Specialist for a hybrid role in Roswell, GA. This position involves working closely with developers in Agile teams to ensure the quality and functionality of applications. Candidates will need a Bachelor's degree in computer science and 2-4 years of experience in...
- Mandatory Skills: Designing scalableMLsystems Advanced statistical modeling Preferred Skills: Leadership inAIstrategy Cutting-edge frameworks (Transformers, LLMs) ROBOTICS TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans...SeniorPermanent employmentContract workLocal area
Robotics Technologies LLC
Alpharetta, GA1 day ago - ...integrations, and confirm that solutions are ready for leadership review, stakeholder demos, and release. The Specialist acts as a key quality gate, ensuring work meets defined requirements before it moves forward. This position focuses on technical QA, works closely with...Work at officeRemote work
- ...Sr. Financial Analyst, Operations The Sr. Financial Analyst, Operations will support any combination of financial and business information, analysis and modeling in support of the company's business objectives. This includes, but is not limited to the annual planning...Senior
Integra Staffing and Search
Roswell, GA2 days ago - Overview TRC Talent Solutions is partnering with a globally established, financially strong semiconductor organization that is aggressively expanding its U.S. headquarters. This is not a backfill role—this is a foundational growth hire. Our site is currently...Senior
TRC Talent Solutions
Johns Creek, GAmore than 2 months ago - ...Sr. Software Engineer Conflux Systems INC has openings for the position Sr. Software Engineer with bachelor’s degree in Computer/Information Science, Engineering any, Technology, Management Information Systems or related and 5 yrs of exp to design, development, implementation...Senior
Conflux Systems
Alpharetta, GA1 day ago - Job Title: Lead Data Engineer Location: Chicago, IL (Remote ok) Duration: 12+ Month Must have skill: Snowflake SQL, Data warehouse, Python, AWS-Lamda, ETL/ELT Job Description: Required Skills: 6-8 years+ experience on Snowflake SQL - advanced SQL...SeniorRemote work
Kasmo Global
Alpharetta, GA5 days ago - ...Sr. Software Engineer ALPHARETTA, Georgia, United States, 30009 Position Type - Contract Mandatory Skills: Java Full stack. OpenShift, API/Web service, Azure integration, SQL Server Job Description: The Sr. Application Developer will be responsible in all phases...SeniorContract work
Echo IT Solutions
Alpharetta, GA4 days ago - Senior.NET Developer (SharePoint Experience) Location: Alpharetta, GA (Hybrid – 3 days onsite) Duration: Contract Rate: DOE Required Qualifications: ~10+ years of overall IT experience, with strong focus on.NET development. ~ Strong hands-on experience...SeniorContract work
Staffing the Universe
Alpharetta, GA4 days ago - ...Position: Sr. Business analyst Location: Alpharetta, GA Duration: 6 Months contract Job Summary: We are seeking an accomplished Senior Business Analyst with at least 15 years of experience to work with our esteemed client. The ideal...SeniorContract work
Equiliem
Alpharetta, GA3 days ago - APO ABAP Developer Visa status: U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. Tax Terms: W2, 1099 Corp-Corp or 3rd Parties: Yes Description APO ABAP DEVELOPER: Level/Experience Required: APO ABAP with good knowledge of working...Senior
Keylent Inc
Roswell, GA4 days ago - ...from Jconnect INC . Below is the requirement with my client. Please let me know if you are available for this role. Title: Sr Developer Location: Alpharetta, GA Duration: Fulltime JOB DESCRIPTION : Skills Desired: Must...SeniorFull timeImmediate startRelocation
3B Staffing LLC
Alpharetta, GA3 days ago - Overview CLOUD ANALYTICS TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without...SeniorPermanent employmentContract workLocal area
Cloud Analytics Technologies, LLC
Alpharetta, GA2 days ago - ...Role - Sr. Java Developer with GCP Location - Alpharetta, GA (Onsite) Exp need -8+ years Job Description Advanced proficiency in full stack Java programming with experience in Spring Boot frameworks and web services Strong experience with...Senior
Diverse Lynx
Alpharetta, GA5 days ago - ...the overall scope of the project; Creating and maintaining a consolidated timeline/schedule highlighting the major milestones and associated dates for project activities; Identifying and communicating project dependencies and impacts; Putting mechanisms in place to...SeniorWork experience placement
InterSources
Alpharetta, GA4 days ago - A leading workforce solutions provider is looking for a Lab Technician in Roswell, GA. This role involves testing product dispensers, troubleshooting issues, and collaborating with engineering teams. Candidates should have a high school diploma and 2-3 years of relevant...
- Job Summary: • Lead the design and implementation of scalable microservices architecture to enhance system performance and reliability • Oversee the development and deployment of RESTful web services to facilitate seamless communication between applications • Provide...Senior
Diverse Lynx
Alpharetta, GA3 days ago - ...Sr Developer Location: Alpharetta, GA Duration: Fulltime Job Description: Skills Desired: Must have skills - Core Java, Spring+Messaging+Camel Designing, coding, testing, and deploying the application. Debugging issues in the application code to...SeniorFull timeImmediate startRelocation
JConnect Infotech
Alpharetta, GA4 days ago - Must Have • 5+ years of SQL Server development experience. • 3+ years ALTERYX Admin /User management experience and advance workflow management. • 5+ years data modeling experience. • 5+ years of ETL experience. • 5+ years of experience in working on more...Senior
Equiliem
Alpharetta, GA3 days ago - ...Responsible for the design, development, rigorous testing, and continuous deployment of mission-critical application components. Code Quality & Reliability: Perform advanced application-level debugging and root-cause analysis (RCA) to ensure optimal performance, stability,...Senior
Intellisoft Technologies
Alpharetta, GA4 days ago - Role: Senior Data Engineer Location: Alpharetta, GA(Hybrid) Duration: Fulltime position Mandatory Skills : Python, Databricks Job description Handson experience in building and optimizing data processing applications using Java and Python ensuring...SeniorFull time
Futran Tech Solutions Pvt. Ltd.
Alpharetta, GA5 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Sr. Quality Assurance Associate. Be the first to apply!
Related searches
- senior compensation manager Alpharetta, GA
- senior vice president of operations Alpharetta, GA
- senior manager creative operations Alpharetta, GA
- senior hvac project manager Alpharetta, GA
- senior financial analyst fp&a Alpharetta, GA
- senior manager accenture Alpharetta, GA
- senior payroll accountant Alpharetta, GA
- senior marketing project manager Alpharetta, GA
- senior litigation attorney Alpharetta, GA
- senior performance engineer Alpharetta, GA