Quality Assurance (QA) Specialist
Company: DCN Diagnostics
Location: Carlsbad
Posted on: May 15, 2022
Job Description:
Job DescriptionSalary: Join the DCN DX team. We provide lateral
flow assay design and development, manufacturing, and clinical
research services to clients all over the world. We are known for
providing high level development and consulting work, education,
manufacturing, and production of POC products including lateral
flow assay reagents. This is a unique document control position/QA
reviewer, where one oversees draft documents in verification and
validation and approved documents in manufacturing. The right
candidate will have knowledge of and worked with ISO 9001 and ISO
13485. Extensive experience in cGMP and manufacturing environment
and FDA Regulation 21 CFR 820. This is a fast-paced job and this
position works with multiple program managers, the assay
development team, and manufacturing.Duties and Responsibilities
- Manage all external registration requirements to ensure they
are met. Liaise with external bodies on all matters relating to
registration. Maintain and improve, in line with business
needs
- Support project design history files in conjunction with the
Project Leads and Project Managers.
- Ensure that all in-house systems and procedures are updated,
revised and modified to meet the needs of external certification
bodies
- Update quality documentation and communicate to carry forward
lessons learned from quality concerns
- Ensure that all necessary systems and procedures are in place
to satisfy all customer requirements and audits
- Introduce new systems and procedures where appropriate
- Train others in all aspects of the quality system and
application of procedures
- Undertake regular internal and process audits of the QMS
- Ensure corrective actions are undertaken to address non
conformities found
- Hold quarterly audit performance meetings within the business
and with Certification Bodies
- Manage the nonconformity and deviation program and associated
tracking logs
- Train and lead employees to perform strong investigations and
risk assessments in associated NCMR, Deviation, and Project
files
- Provide detailed analysis of nonconformities
- Ensure ongoing compliance with the Quality Management System
(ISO13485:2016/ISO9001:2015)
- Attend various meetings and action/communicate
instructions
- Produce written reports and make presentations
- Identify business improvement opportunities within the
organization
- Develop, implement and manage key performance indicators (KPIs)
for each area of responsibility
- Set department objectives/KPIs and review and assess ongoing
performance of direct reports
- Ensure KPIs are met by working to the overall plan, including
management of, and reporting
- Report on achievement of targets and identify any actions
requiredRelationship Management· Develop and maintain strong
relationships with internal and external stakeholders to ensure
optimal performance· Work collaboratively, negotiate and engage
with key stakeholders to facilitate delivery and compliance with
the quality strategy· Liaise and communicate with other
departments, customers, suppliers and other service providers· Work
as part of the Management team to share ideas and improve
operation, recommending, supporting and implementing continuous
improvement activities and process and procedure improvements to
optimize results and improve quality of delivery, in line with
quality standards requirements delivery in line with Company and
Customer requirements· Communicate with personnel at all levels,
internally and externally to the Company, in relation to Quality
matters Requirements
- Maintain confidentiality
- Detail-oriented and meticulous work ethic
- Extremely organized and efficient, expert data organizer
- Proven skill for creating and implementing controlled document
processes
- Work well under pressure and have strong stress management
skills
- Strong oral and written communication skills
- Proclivity for catching errors and enacting appropriate
changes
- Outstanding time-management; able to prioritize and delegate
tasks
- Ability to manage a variety of cross-functional team
members
- Strong interpersonal skills
- Excellent analytical ability
- Archival experienceQualifications
- Bachelor's degree in science, or related scientific field
- 5+ years of relevant experience
- Extensive experience with ISO 9001 and ISO 13485 in design and
manufacturing
- Extensive experience in cGMP and manufacturing environments,
preferred.
- Internal auditing experience preferred
- Proficient in EXCEL and/or other document management software
and web-based tools
- Skilled user of Adobe and Microsoft Suite
Keywords: DCN Diagnostics, San Diego , Quality Assurance (QA) Specialist, Other , Carlsbad, California
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