Quality / Compliance Job Description
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:
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:
Desired experience for quality / compliance includes:
Quality / Compliance Examples
Quality / Compliance Job Description
- 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
- 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
Quality / Compliance Job Description
- 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
- 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)
Quality / Compliance Job Description
- 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
- 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
Quality / Compliance Job Description
- 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
- 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
Quality / Compliance Job Description
- 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
- 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