Quality Compliance Specialist Job Description
Quality compliance specialist
provides guidance and ensures compliance with ISO13485 & 9001, 21 CFR Part 820 and applicable good manufacturing practice regulations within the company.
Quality Compliance Specialist Duties & Responsibilities
To write an effective quality compliance specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included quality compliance specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Provide support to delivery, drive and maintain effective Product Quality Surveillance
Ensure effective global Product Annual / Periodic Product Quality Review
Initiate preparation as per applicable SOP
Support Global System for Product Quality Reviews/Annual Product Reviews
Analyze data to highlight trends that may indicate the need for manufacturing process and specification changes
Communicate PQR/APR findings to responsible officials
Support regulatory reporting and submissions as applicable
Execute additional job duties as requests, analysis and reporting
Representing the quality function to external auditors within business teams or on plant operating teams
Maintains awareness of activities by routine direct observation of testing laboratories and manufacturing suites
Quality Compliance Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Compliance Specialist
List any licenses or certifications required by the position: ASQ, HACCP, PCQI, AS9100, QMS, GFSI, SME, ISO9001, ODOT, NADCAP
Education for Quality Compliance Specialist
Typically a job would require a certain level of education.
Employers hiring for the quality compliance specialist 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, Education, Chemistry, Technical, Biology, Life Science, Life Sciences, Microbiology, Healthcare
Skills for Quality Compliance Specialist
Desired skills for quality compliance specialist include:
FDA regulations
Excel
Good Documentation Practices as it relates to complaint filing
CDPH Regulatory and Licensing requirements
Federal and State Regulatory compliance
Medical terms and human anatomy
TJC standards
21 CFR part 820 and Part 803 and ISO 13485 standard
CGMP regulations for US
MEDDEV Vigilance
Desired experience for quality compliance specialist includes:
Ensures document maintenance is adhered to
Supports the development and maintenance of the regional Quality Management
Support audit related activities including Divisional, Corporate and Regulatory audits actions to addressed audit observations
Bachelor’s Degree in a scientific, technical, or compliance discipline
One to three years in Quality Assurance or another related function in the pharmaceutical, medical device, nutritional or related industry experience
Minimum Science Graduate or equivalent with at least +6 years relevant experience in the Pharmaceutical Industry
Quality Compliance Specialist Examples
1
Quality Compliance Specialist Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of quality compliance 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 quality compliance specialist
- Focused QA Representative on review/approval of Final Reports, CoA’s, Non-Conforming Events (NCEs), Investigations (OOS), and CAPA’s
- Maintain awareness of evolving industry and regulatory trends/regulations
- Lead & Coordinate with Procurement and impacted Site Quality leads on critical audit findings and or audit refusals
- Ensure that plan, policies and procedures comply with regulatory, investor and agency requirements and are incorporated into daily operating procedures
- Be responsible for documentation quality review/approval or audits, documentation maintenance and archival, quality inspections of product, and participating on internal assessments
- Assist in compiling documentation to release R&D studies and will provide guidance on applicable Regulations (FDA, ICH, EU, and others) pertaining to business partners
- Provide GMP documentation review and approval of batch records (Manufacturing, Packaging, and Labeling) and related documents, including Lab, Pilot, and Trial scale batches
- Participate on R&D project teams as the Quality representative
- Work with these groups relative to GMP issues, project plans, due dates, and problem identification and resolution along with assisting in compiling documentation to release R&D studies
- Provide Quality guidance on GMP regulatory requirements (including 21CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 812, 820, Part 11, and Annex 13), including training of R&D personnel
Qualifications for quality compliance specialist
- Minimum of 5 years of experience in the pharmaceutical industry as a quality auditor (CQA), Manufacturing Operations, QC, and/or other cGMP areas
- Knowledge and understanding of the current Good Manufacturing Practices (GMP) and International Conference on Harmonization (ICH) guidelines
- Basic understanding of Biopharmaceutical Manufacturing, Analytical Chemistry and Chemical Manufacturing processes
- Knowledge and understanding of practical quality assurance in the manufacturing environment, laboratory controls and safety
- Ability to read and understand procedures and other controlled documents
- Good written and verbal communication skills, interpersonal skills, and technical writing skills
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Quality Compliance Specialist Job Description
Job Description Example
Our company is growing rapidly and is looking for a quality compliance 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 quality compliance specialist
- Lead policy and procedure review of all imaging policies
- Assist and provide oversight of technical staff’s compliance with CEU, BLS/ACLS, and licensure, certification, and/or registration requirements
- Effectively communicate quality/safety related updates to staff
- Provides education, training, and best practice techniques via written, electronic, or oral presentations to existing staff incoming staff
- Assist in arranging professional development presentations that are approved as Continuing Education Units for technologist staff
- Performs routine audits of records and observes workflows to ensure policy compliance
- Investigate and perform Root Cause Analysis on adverse and safety related events
- Ensure regulatory and accreditation compliance of current imaging and future programs
- Provides updates and/or presentations to various institutional committees (Quality Improvement, Institutional Safety Committee, Radiation Safety Committee)
- Partner with Clinical Laboratory to ensure compliance with laboratory state, federal, and accrediting agency regulations for point-of-care testing
Qualifications for quality compliance specialist
- Ability to support the production and distribution of complex grant and financial monitoring reports (editing, formatting, insertion of charts and tables)
- Strong interpersonal/customer service skills for communication with internal staff and grant recipients
- Fast paced working environment, extensive computer usage
- Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required
- Demonstrated knowledge/application of all quality system elements
- Previous experience in delivering Quality System related training CAPA, Process Validation
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Quality Compliance Specialist Job Description
Job Description Example
Our company is looking to fill the role of quality compliance 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 quality compliance specialist
- Provide support to the Senior Director, Quality & Regulatory Compliance in the development, enhancement, standardization, execution and implementation of processes to manage the notified body audit program
- Research, compile, analyze and report various operational data from multiple sources which could include unit production, productivity and/or quality statistics
- Audit mortgage and intricate loan documentation for accuracy and completeness
- Analyze financial statements, loan documentation and other relevant data to determine best solution
- Act as a liaison to external vendors or other internal departments through consistent phone or email correspondence
- Support and facilitate corporate or T&D compliance and quality management initiatives includes Sarbanes-Oxley (SOX) Compliance quarterly certification, corrective action plan tracking program, Approval Authorization Matrix (AAM) review, critical business records (CBR) initiative, or QA Change Management review
- Obtain and analyze information relevant to quality assessments
- Lead and Facilitate Root Cause Analysis (RCA) meetings, create documentation (Initial impact assessments, RCAs, Final investigation report and Corrective and Preventive Actions) for the review and final approval by the client’s Quality Assurance department
- Bachelors Degree in basic or applied science (preferably with a pharmaceutical and health care emphasis), mathematics, or statistics or equivalent related work experience
- Position requires knowledge of GxP guidelines and regulations with 2-5 years working in facilities maintenance, engineering, or operations organization (pharmaceutical preferred)
Qualifications for quality compliance specialist
- Knowledge of the pharmaceutical industry and cold chain is an asset
- Ability to make constructive recommendations
- Bachelor of Science degree in an applicable field comparable experience
- Minimum of 6 years supporting Quality Compliance with experience in Capital Equipment medical devices
- Experience with CAPA systems (or equivalent) and methodology
- Position requires the coordination and performance of multiple, complex projects while understanding the principles and technical skills related to work assignments
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Quality Compliance Specialist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality compliance 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 quality compliance specialist
- Evaluate the appropriateness and effectiveness of complex corrective actions
- Assist in generating metrics for overall auditing system and identify continuous improvement opportunities
- Develop audit process findings, and may have input to improve process flow for compliance
- Provide training, guidance, and coaching to team members
- Responsible for the handling of change requests from the departments, such as Master Batch Records (MBRs), Specifications (SPECs), General Changes (GENs)
- Develop, check or revise pharmaceutical Quality Agreements
- Develop and execute inspection/audit prep plans and manage the inspection readiness activities (maintain key contact list, prep/strategy sessions, inspection readiness training)
- Working with Engineering/R&D/Product Management and external OEM suppliers, develop design verification and validation (V&V) strategies to support high quality, compliant and best speed-to-market product launches
- Review and approve claim support data and V&V protocols/reports
- Review and approve user requirements/product specifications ensuring input from Marketing/Product Management
Qualifications for quality compliance specialist
- Minimum 3 years’ experience in Quality, Regulatory, Technical, or Manufacturing Operations in the area of regulatory inspections
- Auditor certification or equivalent preferred
- Good knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 11/50/54/56/ 801/803/806/807/820/812/814/821/822, ISO 14155
- Analyze and understand technical and scientific documents, and governing regulatory research information and data
- Possess professional level knowledge of U.S. export regulations including Customs, BIS/ Export Administration Regulations, OFAC and Federal Trade Regulations (Census/FTR)
- 7+ years professional air quality compliance experience
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Quality Compliance Specialist Job Description
Job Description Example
Our growing company is looking for a quality compliance 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 quality compliance specialist
- Organic Compliance
- Kosher Compliance
- QMS Compliance
- Assess the maturity of current Business Unit (BU) processes and practices against the TOMS framework and identify required actions to close gaps
- Support project management, stakeholder engagement and communication activities associated with the implementation of TOMS across the Liquids Pipelines business unit
- Provide subject matter expertise on all aspects of TOMS to Business Unit and BU Program Leaders, including explaining and interpreting element requirements and their intent, providing clarification and setting expectations on enabling tools and processes, and supporting alignment of activities to TOMS
- Develop management system level strategies, standards, processes and tools to support the Business Unit in the implementation of TOMS
- Develop and sustain effective governance structures and practices for the BU Management System aligned to TOMS
- Interact with element and process owners to identify and action improvements
- Prepare required evidence for internal/external audits and generate reports with action plans to close findings
Qualifications for quality compliance specialist
- Knowledge of regulatory and accreditation standards for Imaging required
- Knowledge of regulatory and accreditation standards for Laboratory preferred
- Superb communication (both oral and written), organizational, and problem-solving skills
- Ability to establish collaborative relationships with stakeholders, including, but not limited to, physicians, management, staff, patients, and their families
- Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, pre-medical, legal, or general business core concentration
- Professional certifications and regulatory, quality systems, or internal audit training certificates in relevant disciplines are desirable, although no particular certification is required