Quality / Compliance Job Description
Quality / compliance
provides rigorous assessment of CAPA activities and documentation to assure compliance with CVG CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases.
Quality / Compliance Duties & Responsibilities
To write an effective quality / compliance job description, begin by listing detailed duties, responsibilities and expectations. We have included quality / compliance job description templates that you can modify and use.
Sample responsibilities for this position include:
Audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s)
Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site
Schedule and manage mock inspections as part of External Inspection Readiness activities
Provide timely information to support the inspection process, including those that maybe taking place at other sites / locations
Provide daily inspection communications regarding potential non-conformities
Prepare responses to external inspection or other regulatory notification associated with site
Ensure adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
Establish and execute an effective internal audit schedule for site
Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure
Drive compliance and improvement in internal audit metrics
Quality / Compliance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality / Compliance
List any licenses or certifications required by the position: ASQ, ISO, GMO, CCC, AS9100, QMS, GMP, ACE, 9001, CAAC
Education for Quality / Compliance
Typically a job would require a certain level of education.
Employers hiring for the quality / compliance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and High School Degree in Engineering, Science, Chemistry, Education, Biology, Business, Technical, Life Science, Pharmacy, Microbiology
Skills for Quality / Compliance
Desired skills for quality / compliance include:
Medical terms and human anatomy
Good Documentation Practices as it relates to complaint filing
Regulatory reporting regulations
Excel
Device
FMEA
Validation Programs and SPC processes in a highly regulated environment
FDA regulations
CGMP
ISO 13485
Desired experience for quality / compliance includes:
Self-motivated, independent and able to act without the immediate manager close by
5-7 years experience compliance operations experience in payments, banking, insurance, gaming, or e-commerce with a preferred 2-3 years experience conducting quality assurance of compliance operations
Professional certification in compliance risk management preferred (CAMS/CFE/CFCS certification)
Ability to think 'outside the box' and summarise complex issues into management level statement
Strong written and verbal communication skills and high attention to detail (language skills would be beneficial)
Proficient written and verbal communication skills and high attention to detail (language skills would be beneficial)
Quality / Compliance Examples
1
Quality / Compliance Job Description
Job Description Example
Our company is looking for a quality / compliance. 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 quality / compliance
- To ensure that local quality system and standard operating procedures are in place and that compliance with cGMP is maintained through training & audit
- Assist in the review of Complaint Vigilance Review Board (CVRB) data in preparation for the CVRB meetings
- Review product specifications to ensure that design criteria can be met post launch and over the entire shelf life or design life of the product
- Ensure that Corrective Action/Preventive Action (CAPA) are initiated, assigned, thoroughly investigated, documented and effectively resolved when deficiencies are found during development, testing, manufacturing and in the APR document
- Review and approve all site and applicable corporate SOPs, WIs
- Direct and/or conduct investigations into potential quality/compliance concerns
- Managing the Approved Supplier List (ASL) process for specific parts / supplier restrictions
- Supporting the addition of qualified suppliers, and maintenance of the Qualified Supplier List (QASL)
- Supporting maintenance and distribution of quality compliance and QMS procedures
- Working with central quality compliance to align processes and procedures across UTAS
Qualifications for quality / compliance
- Ability to automate and manual test methods
- At least 5 years+ of proven work experience in the area consumer products compliance and product certification
- BS degree is preferred with a minimum of 4-7 years of experience in quality engineering, facilities design, and production/facility operations or equivalent
- Experience in authoring tools
- A minimum of 4 years of pharmaceutical industry experience with at least 3 years of GCP and/or clinical trial execution experience within clinical development and/or clinical quality assurance
- Strong organizational, interdependent partnering and planning skills
2
Quality / Compliance Job Description
Job Description Example
Our company is looking to fill the role of quality / compliance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality / compliance
- Provide Quality/Sanitation support for project commercialization (Engineering and R&D)
- Establish and maintain robust compliance program
- Partnership with appropriate teams on the formulation of responses to regulatory agencies in order to address observations
- Provide leadership, oversight and strategic guidance for significant regulatory compliance issues at the sites, EMs and suppliers
- Support QScan process
- Manage compliance budget
- Recommend and document remediation for findings and follow up on corrective action ·Make recommendations and develop action plans for continuous quality improvement ·Manage and execute day-to-day Quality and Compliance operational tasks
- Develop, implement and oversee co-packer quality agreements
- The approval (or rejection) of major deviations and changes controls purposed by co-packers
- Assure proper notifications are communicated to both the co-packers and inside of RB
Qualifications for quality / compliance
- Experience with auditing is required
- Experienced in FDA 21CFR Part 820(QSR), 21 CFR Part 803 and 806
- Demonstrated compliance fluency in QSR/GMP, ISO and other regulations
- Bachelor’s Degree in Science (Chemistry, Microbiology or Biology preferred)
- Working knowledge of cGMPs and/or OSHA regulations required
- Work in a regulated environment (healthcare, financial, pharmaceuticals)
3
Quality / Compliance Job Description
Job Description Example
Our innovative and growing company is looking for a quality / compliance. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality / compliance
- To manage all changes that affect the product quality
- To ensure e-Compliance of the computerized systems according to international standards
- To ensure entire qualification / validation activities performed in the site according to GMP regulations
- Review and improve the applicable customer Quality Complaint management processes across the region
- Coordinates training and return of Op Codes
- Able to ensure that organizational processes and the goods and services that result comply with the requirements of standards (e.g., AS9100, ISO 9001), customer, regulatory, and AEC requirements
- Participate in quality, process and product audits
- May be required to develop internal quality system training
- Providing the business with intelligence in respect of the customer's journey across Sales & Service
- Develop data quality and research audit plans, including objectives and testing criteria for how the audit shall be conducted
Qualifications for quality / compliance
- Monitoring the quality performance of existing co-packers using performance metrics and ensuring their activities are fully compliant with applicable regulations
- The approval (or rejection) of new co-packers
- Work closely with Procurement, Factory Operations and other Quality groups to resolve quality issues with co-packers that may affect consumer safety, regulatory compliance, customer satisfaction and operational performance
- Partner with co-packers and internal departments to develop improvements at co-packers when necessary
- Maintain knowledge of current regulatory and industry compliance trends and adopt co-packer qualification program strategies as appropriate
- Maintains co-packer quality assurance program
4
Quality / Compliance Job Description
Job Description Example
Our company is growing rapidly and is looking for a quality / compliance. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality / compliance
- Primary responsibility for all quality systems with CFS
- Responsibility for QA operations across multiple sites, or region, or within a single location where local management or regulatory support is limited (eg Asia Pac).*
- Designs and delivers training as necessary to enhance regulatory awareness within their area(s) of responsibility
- May be required to assume responsibilities of Site Operations in the absence of the Site Operations Head
- Conducts and hosts client visits to CFS
- Quality and Environmental Systems – Responsible for business unit and plant level policies and processes
- Government and Regulatory Systems – Performs work to generate proof of compliance with various needs of government agencies and customers
- Benefits including Medical, Dental and Vision coverage, Paid time off and 401K
- Know and understand federal, state, and local food industry regulations and company policies as applicable to operations of facility (CFR, GMPs, SSOPs, HACCP)
- Read and understand the Footprint creation SOP
Qualifications for quality / compliance
- US and some international travel to audit co-packers
- Work closely with different organizations within the business to resolve any issues with co-packers
- Propose quality improvements to co-packers and monitor implementation
- Coordinate with distribution personnel quarantine of stock where there is doubt on assurance of quality, safety and efficacy of finished products to be sold
- Prefer BS/MS degree in a scientific or engineering discipline or equivalent experience
- Minimum of 5 to 8 years’ experience in pharmaceutical and/or dietary supplement industry in Quality Assurance with at least 1 year participating as a lead GMP auditor role
5
Quality / Compliance Job Description
Job Description Example
Our growing company is looking for a quality / compliance. 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 quality / compliance
- Retrieve cartons with missing footprint from the inbound dock floor
- Create footprints for inbound receipts and other areas of the distribution center as needed
- Report all footprint discrepancies to management
- Cross train and support Quality and Vendor Compliance Auditors
- Review lab data on a daily basis
- Leading departmental activities, including training of new and actual employees under his leadership, governance, and appropriate deliveries to our Stakeholders
- Responsibilities regarding JJRC (Corporative Audits) - Preparation, audit and actions
- Preparation and submission of Dashboard items
- Commercial Support to the sales team, along with the Go To Market strategy with direct involvement in quality improvement activities, delivering CIP and Cost Avoidance related to product quality
- Leadership of DPS activities in the launch of NEW Products – Specially Trauma and Spine, totaling the involvement in 14 projects of launches for 2017/2018
Qualifications for quality / compliance
- Knowledge of pharmaceutical/dietary supplement quality industry regulations FDA, GMP, GLP, ICH Q7, 8, &9
- Minimum of 3 years of expeience in QA, including Quality Systems, Standards, Metrics, and Tools
- Demonstrated knowledge and expertise in developing schedules for the management for Quality Systems
- Ability to use the AGILE document control and AGILE CAPA systems
- Experience in ComplianceWire training system and demonstrated ability to develop user groups and training curriculums within that system
- Strong working knowledge of the AGILE document control system and AGILE CAPA system