Quality Operations Job Description

Quality Operations Job Description

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Quality operations provides SME expert GCP advice to Clinical Development based on analysis and interpretation of updates to GCP regulations to assure best clinical practices are follows.

Quality Operations Duties & Responsibilities

To write an effective quality operations job description, begin by listing detailed duties, responsibilities and expectations. We have included quality operations job description templates that you can modify and use.

Sample responsibilities for this position include:

Oversee the development and implementation of quality assurance plans for clinical programs
Lead & supervise a team of area managers (front-line supervisors) & hourly associates in Inventory Control / Quality Assurance operations within the fulfillment center
Ensure the application of the Group Quality, Customer Satisfaction, Quality Assurance policies, and the Group Reference system
Develop strategies to improve adherence to healthcare guideline
Responsible for healthcare-related audits
Oversee all processes related to the collection and review of the medical records
Supervise staff assigned to project support
Follow procedures associated with job functions
Perform and complete analysis for manufactured products and promptly file test reports
Operate Automated Hematology Analyzer to perform cell counts and perform manual counts

Quality Operations Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Operations

List any licenses or certifications required by the position: ASQ, QMS, CQE, CQA, ISO, PMI, SQF, TS, QP, QHSES

Education for Quality Operations

Typically a job would require a certain level of education.

Employers hiring for the quality operations job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Science, Chemistry, Technical, Pharmacy, Education, Biology, Manufacturing, Management, Microbiology

Skills for Quality Operations

Desired skills for quality operations include:

Chemical
SPC
ISO 13485
Quality assurance
GCP
Process capability studies
Biological
Clinical development
Industry best practices in order to provide guidance
Pertinent regulations

Desired experience for quality operations includes:

Operate biosafety cabinets, incubators, microscopes and any other instrument in QC laboratory
Evaluate and prepare samples requiring testing
Ship client/donor and product samples to testing facilities
Assist with equipment calibration program
Assist with Environmental Monitoring program as directed
Perform raw material inspection and approval as needed

Quality Operations Examples

1

Quality Operations Job Description

Job Description Example
Our growing company is hiring for a quality operations. 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 operations
  • Work with Module Centers and Supplier Quality and the customer to ensure an effective MCAP process
  • Lead the ACE journey for Operations and Aftermarket Quality
  • Provide leadership and coaching for the Quality Control team & ensure the timeliness of testing of our products manufactured- Support & participate in the plant-wide efforts to reduce scrap and rework costs, and to identify root causes and solutions for quality defects
  • Quality oversight for decisions regarding quality and compliance for all batches and products, including discrepant batches (investigations, retesting and re-inspections)
  • Be recognized as an expert in identifying and defining quality expectations of internal and external customers
  • Develop and implement robust quality systems and data analysis
  • Support Product Development Process for the Division to ensure new products are developed robustly in a risk-based approach
  • Responsible for composition and review of quality related investigations
  • Responsible for quality review and approval of related Process Validation and Technical Transfer GMP
  • Directs the work activities of analytical testing groups to assure product and components comply with specifications
Qualifications for quality operations
  • Managed a plant-based organization (Quality or Operations) with multiple challenges
  • Degree level qualification or equivalent in an Engineering or Science Discipline
  • Minimum 5 years experience in a senior quality role within a regulated industry
  • With a minimum of 10 years experience in a managerial position
  • Must have a BS degree in a technical discipline
  • Preferred strong provider claims experience
2

Quality Operations Job Description

Job Description Example
Our company is growing rapidly and is hiring for a quality operations. 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 operations
  • Coordinate CAPA and sub-system investigations
  • Prepare client audit responses and follow-through of corrective action commitments
  • Communicate with clients regarding the investigation as necessary
  • Partner with departments to perform Quality, PAR, CAPA, ACAR investigations
  • Track LIRs, NCEs, address client complaints, and assist with completion
  • Track implementation and training resulting from CAPA, and assist with training
  • Communicate with clients regarding technical and nontechnical questions pertaining to the investigation status
  • Train in multiple laboratories to receive working knowledge of testing
  • Establishes goals and monitors performance through monthly, quarterly and annual summaries and metrics
  • Facilitate, participate, review, lead and/or approve Investigations, root cause analysis Change controls
Qualifications for quality operations
  • Established expertise and training in GxP systems
  • 2-5 years other Pharmaceutical or related industry experience or combination with QA experience may be considered
  • Requires an understanding of the principles of, and the ability to perform statistical analyses (familiarity with Minitab software preferred, with understanding of 6-sigma process principles, graph generation)
  • Knowledge of computer systems and software applications
  • Experience with SAP material management software, TrackWise, Veeva Vault or other electronic document management system highly preferred
  • Conduct scheduled internal compliance checks as necessary
3

Quality Operations Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of quality operations. 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 operations
  • Ensure the effectiveness of the “alerting and vetoing” process
  • Approve the conformity of products and building blocks and follow up on customer complaints
  • Generate documentation to support the task delivery and business reviews
  • Investigate and analyse quality data and metrics and initiate improvements
  • Pursue the standardisation of audit processes
  • Ensure that the Quality Management system is functioning properly
  • Interface with other Quality functions to ensure best practice and standardisation
  • Develop credible relationships across the Operation function to input into pragmatic solutions to eliminate and mitigate issues and risks
  • Understanding the current process state
  • Value stream mapping for QC operations - identify processes with high hands on time and VSM for interactions with all suppliers and customers
Qualifications for quality operations
  • Minimum of an Associate’s or Bachelor’s degree, or equivalent experience or education, and 2-4 years experience is required
  • 6-8 of years related experience required 3-5 years leadership experience
  • A minimum of 10 years of quality and/or manufacturing experience in medical device field is required
  • In-depth knowledge and hands on experience with all elements of ISO/QSR requirements applicable to medical device design and manufacturing is required
  • The ability to influence at senior levels and across functions building strong networks internally and externally is required
  • Solid experience in a Quality or Operations environment with a reputation in change management
4

Quality Operations Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of quality operations. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality operations
  • Identifying efficiency/improvement opportunities
  • Design the future state process which reduces wastage and improve efficiency
  • Derive the implementation plan to roll in the future state process
  • First line leader for QA
  • Ensure the Radiation Safety Program is implemented
  • Supervise Quality Solutions NDE and QC staff
  • Conduct pre-job briefs and project readiness reviews with NDE and QC staff
  • Maintain, repair, and purchase NDE and related equipment
  • Deal with and staff customers’ needs
  • Dispatch and staff customer service requests and projects
Qualifications for quality operations
  • In-depth knowledge in the applicable regulations (GMP, ISO )
  • Must possess written and verbal communication skills, interpersonal skills, strong work ethic, strong attention to detail skills, consensus gathering skills, strong organizational skills and a strong working knowledge of PC based systems including, Microsoft Office including Word, Excel and internal e-mail system
  • Degree qualification or equivalent in relevant discipline
  • Ideally you will be a member of CQI although we will support you through this if you are not a member
  • Managerial skills with ability to lead and develop teams
  • Demonstrated ability to effectively develop and manage both internal and external relationships with a broad range of stakeholders including senior management, floor level operations, customers, and key regulatory stakeholders
5

Quality Operations Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of quality operations. 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 operations
  • Work with Business Development staff to bid jobs and assist customers with estimates
  • Help technicians with technical questions as needed
  • Work with RSO to maintain radiation records
  • Maintain calibrated equipment
  • Purchase NDE and shop supplies
  • Lead Quality Governance Committee
  • Become the primary driver for “Brand Promise' Quality commitments and improvements to our customers
  • Analyze feedback from the field to prevent recurring problems
  • Responsible to communicate to Suppliers, RB Quality Standards & requirements
  • Ensure that for every Project (Change, New Product, Extension of Product or Cost reduction)
Qualifications for quality operations
  • Some year supervisory/management experience
  • Knowledge of basic quality tools, risk analysis, statistics
  • 2+ years is preferred
  • Review pertinent documents, records and reports such as Manufacturing Batch Records, lab test results, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on Good Documentation Practices, regulatory requirements and internal guidelines
  • Determine the logic, adequacy and effectiveness of Quality processes, systems and related requirements
  • Must be self-motivated, an effective communicator

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