Compliance / Quality Specialist Job Description
Compliance / quality specialist
provides compliance support for the development and/or ongoing review for applicable compliance and regulatory requirements, including licensing, data protection, anti-money laundering, anti-bribery, anti-fraud, product compliance, etc.;.
Compliance / Quality Specialist Duties & Responsibilities
To write an effective compliance / quality specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included compliance / quality specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Support and facilitate delivery of products entering the in-line supply chain into Quality Systems
Ensures site quality and compliance systems follow regulatory requirements are operational and support manufacturing, and are communicated and understood across the organization
Interact with MFG management to provide quality perspective on routine operations and support systems
Perform trending of data and quality systems as relates to NCEP, CAPA metrics and other trending, as required
PREVENTION-Review customer quality expectations for labeling, packaging, routing and shipping and consolidate into a practical and comprehensive resource for the supply chain
RECOGNITION-Evaluate accounting reports and/or customer compliance alerts
INVESTIGATE-Root cause analysis of issues to identify actual gap in SOP and/or communication and what is needed to prevent recurrence of the problem
DRIVE THE SOLUTION-Meet with GBT, distribution, sales, customer service and/or account to identify solutions based on effectiveness, ease, cost and impact
Monitoring and supporting the quality performance of contract manufacturers and distributors to all applicable GMP & GDP
Conducting record review of executed batch records for bulk fill CMO operations
Compliance / Quality Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Compliance / Quality Specialist
List any licenses or certifications required by the position: ASQ, HACCP, PCQI, AS9100, QMS, GFSI, SME, ISO9001, ODOT, NADCAP
Education for Compliance / Quality Specialist
Typically a job would require a certain level of education.
Employers hiring for the compliance / quality 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 Compliance / Quality Specialist
Desired skills for compliance / quality specialist include:
Anti-Money Laundering and OFAC regulations
Applicable US FDA
QMS and CAPA related tools
Controlled substances desired
Excel
Insurance requirements and third party billing
MS Office/Word
Outlook and aptitude for new programs
Quality and compliance standards at the state and federal levels
Systems
Desired experience for compliance / quality specialist includes:
Reviewing deviations and can distinguish between minor, major and critical
Preparing all paper work for product disposition (bulk and finished product)
Reviewing change controls for impact to disposition
Providing support for investigations of product compliant
Preparing drug product annual review report sections
Supporting relevant regulatory filing updates and inspections
Compliance / Quality Specialist Examples
1
Compliance / Quality Specialist Job Description
Job Description Example
Our company is growing rapidly and is looking for a compliance / 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 compliance / quality specialist
- Monitors remediation/CAPA activities
- Independently serves as Quality Compliance representative in decision making and conflict resolution with junior team members as needed in the absence of the department head
- Serves as Subject Matter Expert for internal or external matters
- Mentors, trains and coaches new auditors as required and supports the development and implementation of training programs
- Assists in the Foreclosure Mitigation Quality Control and Compliance review processes by assisting with review of contractor reports, Grantee audit reports, Grantee site visit reports and responses of Grantees
- Provides direct customer service to Foreclosure Mitigation Grantees by responding to telephone calls, email inquiries and requests for information
- Contact for on-site client visits
- Responsible for the development and mentoring of junior and mid-level staff members
- Responsible for development, modification, implementation and execution of Quality Assurance programs (GMP, CFIA, ) in Distribution Centres
- Perform root cause analysis, investigations, related to NCEP and CAPA issues
Qualifications for compliance / quality specialist
- Knowledge Medical Device/Combination regulations
- In-depth knowledge of Pharmaceutical Operations
- Experience in FDA Regulatory Inspection support
- Ability to overcome discrepancies in interpretation of quality and compliance requirements
- Ability to influence and negotiate areas of GMP regulatory requirements and expectations
- Ability to enter into highly different cultural and regulatory backgrounds worldwide
2
Compliance / Quality Specialist Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of compliance / quality specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for compliance / quality specialist
- Handle GMP documentation maintenance, storage, and archival process, including the daily activities supporting this process
- Participate in the development and implementation of GMP and Quality & Compliance processes and procedures
- Participate on and perform internal assessments of R&D GMP processes and areas
- Participate in inspection readiness activities
- In collaboration and consultation with the members of the Research Compliance team within the Office of Research, develop, implement and maintain educational training programs, coordinate educational content, and incorporate current technology with the aim of raising awareness amongst, and training and educating all stakeholders in all areas of research compliance and responsible conduct of research
- Evaluate training initiatives using tests, questionnaires, and/or other evaluation methods to measure the effectiveness of curricula, and use the evaluation outcomes to inform future educational initiatives
- Serve as the lead of an Imaging Quality and Safety Committee and participate as a team member on various institutional and departmental committees
- Facilitate meetings, develop action plans, and hold stakeholders accountable for applicable QAPI initiatives
- Lead efforts to extract new data/reports specific to quality and safety from various system databases
- Analyze and compile data into professional presentation and reporting formats
Qualifications for compliance / quality specialist
- BS in chemistry, biology or related field with 2+ years’ experience in leading investigations/change controls in a cGMP environment
- Requires BS/BA in scientific discipline or related field with 3-5 years of related work experience in pharmaceutical or related industry
- Working knowledge or experience with audit techniques, concepts and standards
- Willingness to obtain other certifications, if required
- Demonstrated knowledge of and adherence to federal, state, and other regulatory standards, requirements, and guidelines related to clinical trials research
- Strong working knowledge of ongoing monitoring techniques (including criteria development and trending)
3
Compliance / Quality Specialist Job Description
Job Description Example
Our company is searching for experienced candidates for the position of compliance / quality specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for compliance / quality specialist
- Provide input, based on understanding of international standards and regulations, to business unit and/or corporate quality initiatives including special projects, such as designing and/or recommending systems, procedures
- Provide input and may lead projects, based on understanding of international standards and regulations, to business unit and/or corporate quality initiatives including special projects, such as designing and/or recommending systems, procedures
- Partner with Biomedical Engineering to ensure device calibration/compliance
- Participates in clinical research activities and assists with regulatory and compliance-related tasks
- Customer Service and Technical Assistance
- Assist with the initiating and reviewing of fund recapture and/or de-obligation procedures as necessary and follow-up with grantee to resolution
- Assist with the development of future grant rounds, including application and user guide design and development, coordinate and assist in delivering pre-application information sessions to explain application process and criteria, and study grant recommendations and impact analysis
- Provide training to grantees (via WebEx and other methods) to ensure understanding of project requirements
- Perform delegated responsibilities as designated by the supervisor in his/her absence
- Assist with maintaining, updating and periodically revising risk-scoping to determine which grantees receive on-site reviews, as necessary
Qualifications for compliance / quality specialist
- Demonstrated ability to work in a team-based, collaborative environment
- Ability to extract data and run reports from databases
- Ability to prioritize and coordinate multiple work activities in a fast-paced team environment and meet critical deadlines
- 10% potential domestic or international travel
- Must have experience in environmental compliance, air permitting
- Title V air quality permitting
4
Compliance / Quality Specialist Job Description
Job Description Example
Our company is looking to fill the role of compliance / quality specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for compliance / quality specialist
- Monitor, evaluate and maintain knowledge of industry standards and recommended practices for management systems
- High degree of computer literacy including excellent written and oral communications skills preferred
- Ability to identify Compliance Risks within responsible area
- Six Sigma, Process Improvement, and or Flow Mapping experience preferred
- Performs phone quality reviews
- Manage the Corrective Action Request (CAR) system and hold regular meetings to discuss them oversee the timely completion of all Root Cause and Corrective Actions, interfacing with customers whenever needed
- Ensure that during the life-cycle of all projects relevant to lab compliance and continuous improvement, support is provided to all activities required to deliver results in a timely manner
- Evaluate the appropriateness and effectiveness of corrective actions
- Collaborate with team members and/or management to plan annual audit schedule, determine and assign SMEs to audits, establish audit content, allocate time, and schedule meetings
- Execute audits considering scope to assure efficient and effective use of scheduled time allocations
Qualifications for compliance / quality specialist
- 5 or more years of work experience in Quality Assurance (food safety could be an asset)
- Bachelor of Sciences is a minimum
- Undergraduate degree in food science is considered an asset
- Coordinate special projects within the area/division
- Ability to oversee temporaries and permanent personnel on temporary assignment to area
- Direct Facilitation of US and EU Regulatory Inspections principle Customer Audits
5
Compliance / Quality Specialist Job Description
Job Description Example
Our company is looking to fill the role of compliance / 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 compliance / quality specialist
- Provide independent assessment and advice during design review meetings
- Provide expertise as a subject matter expert (SME) for Design Control as per ISO13485, FDA QSR Part 820 and other international regulatory requirements
- Provide expertise as a SME for Risk Management as per ISO14971 and other international regulatory requirements
- Provide expertise as SME for global certification of electro-mechanical products including CB reports, CSA
- Coordinate with Engineering/R&D team members to ensure that electrical safety/EMC testing is performed as required to IEC 61010
- Review and approve design transfer plans and activities to ensure effective design transfer from Engineering/R&D to manufacturing & Service
- Participate in new product post launch support teams and prepare post market review data/metrics for management/stage gate review
- Support the preparation of CE Technical Files to demonstrate compliance with In-vitro Diagnostic Device, Medical Device, Low Voltage & Machinery Directives
- Evaluate and approve proposed product design changes (member of ‘Change Review Board’) and give direction on testing/verification/validation requirements needed for change approval
- QWS
Qualifications for compliance / quality specialist
- Bachelor Degree in Engineering, Biology, Chemistry or related field
- Advanced Career Experience in a GMP environment and in Quality Assurance or similar discipline
- The position will be located in Skillman, NJ and may require up to 10% travel.R&D
- B.S., B.A., or M.S
- Knowledge of FDA 806 & 803, MEDDEV Vigilance, QMS requirements (QSR820 and ISO 13485 / ISO 9001)
- Associate’s degree required, Bachelor’s degree in Science, Healthcare Administration, or Management strongly preferred