Sr. QA Analyst
Company: QualStaff Resources
Posted on: May 12, 2022
Job DescriptionSr. QA Analyst Summary:Key contributor to the
administration of the following compliance functions: DHF
documentation review, Corrective and Preventive Action (CAPA) and
Internal Audits. Assist management to ensure that products,
procedures, processes, contracts and services comply with
applicable federal and state rules and regulations; as well as
internal standards. Essential Duties and Responsibilities:
- Review Verification and Validation protocols and executions for
accuracy and completeness.
- Review DHF documentation for content and completion of required
deliverables. Provide guidance as necessary to ensure appropriate
content on documentation and verification of accuracy.
- Review and audit DHF documentation assuring traceability with
- Review CAPA documentation for content and completion of
required deliverables. Provide guidance as necessary to ensure
appropriate depth of investigation and corrective and/or preventive
actions. Assess effectiveness of corrective and preventive actions.
Prepare CAPA Review Board meeting agenda and minutes.
- Review nonconformance trending to identify need for corrective
or preventive actions.
- Perform Internal Audits as Lead Auditor or member of the Audit
Team. Participate in audit preparation, execution and audit
reporting. Track completion of audit responses and verify
effectiveness of actions taken.
- Compile CAPA and Internal Audit performance metrics for review
- Perform duties of Recall Coordinator in association with the
Company's Corrections and Removals Policy.
- Create or revise Standard Operating Procedures and Work
Instructions governing the Company's compliance functions.
- Assist management with continuous improvement of processes and
systems supporting the Company's compliance functions.
- Stay current on applicable FDA, ISO and other applicable
industry requirements. Monitor external publication sources for
issues applicable to the Company.
- Create training materials and execute training as necessary to
communicate process requirements and provide guidance to user
- Conduct investigations into potential quality / compliance
concerns. Keep management informed of issues.
- Perform other tasks as assigned to enable organizational and
quality objectives to be met. Required Qualifications:
- Minimum 4 years of Quality Assurance or Compliance experience
in the medical device and/or pharmaceutical industries.
- Good understanding of QMS as applied to medical devices.
- Experience can substitute for degree requirements.
- Ability to add, subtract, multiply, and divide in all units of
measure, using whole numbers, common fractions, and decimals.
- Ability to compute rate, ratio, and percent and to draw and
interpret bar graphs.
- Ability to define problems, collect data, establish facts, and
draw valid conclusions.
- Ability to interpret an extensive variety of technical
instructions in mathematical or diagram form and deal with several
abstract and concrete variables. Preferred Qualifications:
- Direct experience with Nonconforming Material, CAPA, and
Internal Auditing preferred.
- Quality System Auditor / Lead Auditor certification
desiredFunctional DescriptionSupports the organization with initial
compliance and ongoing preparation, testing and monitoring of
conformance to established quality assurance processes and
standards for manufacturing and production. Performs evaluation of
internal controls, communications, risk assessments and maintenance
of documentation as related to compliance with internal and
external safety, quality, and regulatory standards. Identifies risk
and evaluates deficiencies while working with internal
departments/business units to appropriately remedy them.
Facilitates internal training on quality assurance requirements,
processes, and procedures. May perform audits and risk assessments.
- A seasoned, experienced professional with a full understanding
of area of specialization; resolves a wide range of issues in
- Demonstrates further technical development and a track record
of project success.
- Demonstrates an ability to coordinate multiple projects
- Considered a specialist in the field within the function.Scope
- Assists in determining objectives of assignment. Plan schedules
and arranges own activities in accomplishing objectives.
- Works on problems of diverse scope where analysis of data
requires evaluation of identifiable factors.
- Networks with senior internal and external colleagues in own
area of expertise.Judgement
- Demonstrates good judgment in selecting methods and techniques
for obtaining solutions.
- Normally receives little instruction on day-to-day work,
general instructions on new assignments.Experience and Education
- Typically requires a Bachelors degree and a minimum of 5-8
years of related experience.
Keywords: QualStaff Resources, Mesa , Sr. QA Analyst, Professions , Mesa, Arizona
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