Product Quality Specialist Job Description
Product quality specialist
provides support and expertise related to cGMP and FDA compliance for the manufacturing plants and pilot operations.
Product Quality Specialist Duties & Responsibilities
To write an effective product quality specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included product quality specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Product Quality representative in NPD including quality planning
Draft the management summary statement for the Annual Product Reviews and Product Quality Reviews
Track cost of quality data
Leads or participates in product quality investigations to effectively resolve and share learnings from incidents
Work with project teams and manufacturing plants on plans to accelerate improvement on outlier models with high SIR to support the Category Quality Vision
Re-earned trust with dissatisfied customers by providing technical solutions to their quality issues
Provide insights for the Master House of Quality to create visibility to consumer needs shown in the 5 star reviews, SIR, CUFT, and CPSM
Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls
Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI’s Quality Systems
OInputs all received product quality complaints into the electronic complaint system
Product Quality Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Product Quality Specialist
List any licenses or certifications required by the position: HACCP, CSM, JAWS, CPWA, CPACC, OPEX, VWR, BRC, AMT, ASCP
Education for Product Quality Specialist
Typically a job would require a certain level of education.
Employers hiring for the product quality specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Chemistry, Science, Manufacturing, Technical, Biology, Education, Microbiology, Business, Medical
Skills for Product Quality Specialist
Desired skills for product quality specialist include:
CGMP and regulatory principles in a pharmaceutical manufacturing environment
Manufacturing electrical
Quality
DEA and FDA
EP
Electronic and electrotechnical systems
GMP
ICH
JP
Experienced in reading schematics for circuit designs
Desired experience for product quality specialist includes:
Assist in the circulation of the completed APR for review and approval
Support Regulatory Affairs In collection of chemistry, manufacturing, and controls (CMC) data from Contract Manufacturing Organization (CMO)
Responsible for review of highly complex transactions such as foreclosure affidavit documents, complaints, deeds, substitution of trustee
Product batch disposition preparation in accordance with priorities and inventory demands
Conducting record review of executed batch records
Performing review of records
Product Quality Specialist Examples
1
Product Quality Specialist Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of product quality specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for product quality specialist
- Provides PQC data to support Metrics, APRs, Quality review forums, as needed
- Provides directed support to all GMP eQRMS Modules including CAPA, Deviation and GCM
- Support the implementation of new and/or enhancements to the existing electronic quality system platforms
- Primary quality liaison for clients and internal customers
- Analyze weekly 5-star reviews and highlighting wins and gaps for the extended Refrigeration team
- Partner with engineering, manufacturing, procurement to accelerate improvements on Jenn Air and KitchenAid products
- Guide outbound calling activities to reveal actionable insights or validate improvements
- Review 5-star customer ratings and comments regularly
- Coordinate outbound calling for projects or products to better understand key consumer issues and to develop countermeasures with the project teams
- Call customers and/or technicians to better understand failure modes driving poor star ratings or issues with premium product
Qualifications for product quality specialist
- Lead Customer Instruct content enhancement, including company website multimedia (product install and use videos, normal operating sounds, etc), product literature, labels, user interface wording
- Provide oversight in product development to predict & prevent potential customer instruct risks
- Utilize field data to identify areas of high Customer Instruct and drive improvements
- Drive improvements with process partners reduce install and instruct service calls
- Develop compelling product communications content (literature, labels, and website FAQs)
- Data analysis and project management - develop a deep understanding of consumer needs, product operation, and consumer instruct and installation issues to champion improvement within physical product
2
Product Quality Specialist Job Description
Job Description Example
Our company is growing rapidly and is hiring for a product quality specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for product quality specialist
- Collaborates with manufacturing and quality personnel in monitoring the manufacturing process, preparing and reviewing documents
- May present Product Quality Review data to senior management, regulatory agencies, and business partners as needed
- Improve the integrity and accuracy of the 5 star reviews through website review moderation
- Participate in tabulation and assessment of departmental and global metrics Annual Report compilation for Commercial Drug Products
- OReviews received documentation and works with the Initiator group for follow-up activities
- OPerforms Complaint classification and severity assignment
- OPerforms Unit trending for Complaint
- OFacilitates sample return with Designated POC/ Logistics for return product assessments
- OIssues Management Notifications for Critical complaints
- OGenerates and distributes response letters, as applicable
Qualifications for product quality specialist
- Educated to degree ideally B.Sc
- Must possess technical and scientific knowledge
- Provides oversight for PQC Process
- OPerforms weekly reconciliations with Drug Safety/ Affiliates
- OForwards weekly list of closed complaints to the appropriate Drug Safety departments
- OProvides a monthly reconciliation lists to Customer Care/order Processing/Medical Information
3
Product Quality Specialist Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of product quality specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for product quality specialist
- Participate in quality alerts or quality manual changes as needed to meet cGMP requirements
- The successful candidate will have accountability for drug substance batch release and related duties under GMP, ensuring compliant clinical drug substance supply
- Develop and implement efficient business solutions and effective quality processes
- Develop and apply expertise, provide guidance and interpretation of Good Manufacturing Practice (GMP) and related regulatory requirements, standards, and guidance documents
- Author, review, and/or approve procedures (SOP) within Quality and for or with functional areas
- Coordinate the alignment of QC labs deliverable link to testing of lifecycle product improvement projects in line with Global supply chain objectives in terms of quality, time and cost
- Global SOPs, Work Practices, Job Aids
- OResponsible for providing Training as SME on Complaint Process
- OResponsible for maintaining and updating Complaint SOPs, Work Practices, Job Aids and Training Materials
- OSupports enhancements and upgrades to complaint system and user acceptance Testing
Qualifications for product quality specialist
- A minimum of two to three years of financial services operations experience
- OManages User community feedback to implement process Improvements to eQRMS
- OSupports ad hoc requests from customers
- OSupports Senior Management Review meetings with PQC data
- OSupports Monthly Metrics Report generation
- Provide broad support to GQS Systems and Business Process Owners
4
Product Quality Specialist Job Description
Job Description Example
Our innovative and growing company is looking for a product quality specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for product quality specialist
- Develop, execute and implement a robust and compliant APQR program which meets all regulatory requirements and according to Novartis Corporate Quality Manual and relevant NTO GOPs
- Establish APQR CGT local business community to ensure all key quality system SMEs and business process owners (BPO) provide data and information on time and in full to meet regulatory and internal timelines
- Provide updates to all relevant quality committees and boards cockpit KPI reporting for on time completion of APQRs
- Provides directed support to the QUADs Project/System
- Support process harmonization across domestic and international sites
- Assists in the implementation of new practices/systems in keeping with constantly changing/emerging FDA/industry requirements
- Complete finished product release evaluation including
- Verifies complex product conformance to design requirements
- Develops inspection and surveillance plans
- Provides feedback and recommends solutions to ensure process compliance
Qualifications for product quality specialist
- Performs preliminary review and disposition of complex non-conformities
- Coordinates and conducts product review with customer during product or process verification
- Provides expertise and leadership to customers and team members in all areas of product verification and acceptance
- Materials Review Board (MRB) and/or corrective action experience
- Experience in a Defense or Space related program
- Experience with the following types of hand tools (calipers, digital optical micrometers, depth gages, thread gages, go no go gages)
5
Product Quality Specialist Job Description
Job Description Example
Our company is growing rapidly and is looking for a product quality specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for product quality specialist
- Provide education and guidance for Data Quality specialists, development of standards and continuous improvements
- In support of the Clinical Applications - occasional operational responsibility for the provision of Data Quality support and Training services and facilitating resource to project/minor work / service requests as appropriate to support the contract
- Lead the review of material, process and finished goods food safety and quality risk assessments
- Research and develop controls systems to support quality and food safety risk mitigation in new or novel products and processes
- Support the development of compliance (QMP, FSSC-22k) quality and food safety systems within our global pilot plant community
- Provides QA support for regulatory submissions
- Works with contractors to ensure that company and contract facilities pass an FDA team biologics inspection
- Serves as audit host for all regulatory inspections for company and contractors
- Directs audit program to review facility and equipment qualifications of contract manufacturers and suppliers to ensure compliance with company and regulatory specifications for purity, size, and durability
- Trains clinical staff in the proper collection and submission of data and in questionnaire development
Qualifications for product quality specialist
- Experience inspecting cleaning, priming and Thermal Protection System (TPS) activities
- More than 5 years of experience in the inspection of parts, components, assemblies or units
- Experience utilizing and following detailed work instructions, reading and interpreting blueprints and schematics, drawings, or specifications
- Has a limited understanding of the job
- Moderate understanding of general job aspects and basic principles, theories, and concepts
- Identifies routine problems and seeks guidance when developing solutions