Job Title – QA Technician III

Location - San Diego, CA

Duration – 8+ Months Contract

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
1st Shift onsite
• Work hours: 7-4/8-5. I am open to either. 40hrs per week.
 

3 Must haves on the resume:
o Attention to detail
o ISO 13485/9001 experience
o Flexible, okay with not having same routine every day.

Job Summary:
Quality associates support the development and implementation of programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement. They support the development of policies, procedures, and methods to check product, material, components and/or operational quality and improve same. They are responsible for supporting the development and implementation of a compliant and cost-effective quality system that assures products and services are reliable, safe and effective.

The QA Technician is responsible for overseeing and maintaining the in-process and final inspection methods and processes. Recognizes process improvement opportunities and works with teams to implement changes. Drives both department and business objectives.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Primary Responsibilities:
Responsibilities:
1 Consistent application of Quality System standards to assigned area.
2 Develops solutions to routine assigned activities of limited to moderate scope & complexity.
3 Follows applicable Company / Unit procedures and may make updates to procedures and policies
4 Proactively manages group and/or personal metrics to ensure goals are tracked and met.
5 Works within and across functions for assigned Quality systems

The QA Technician III works on assignments that are moderate to complex in nature where judgement is required in resolving issues and making routine recommendations. Normally receives no instruction on routine work, general instructions on new assignments. Exercises judgement within defined procedures and policies to determine appropriate action.

The QA Technician III applies experience to complete assignments and facilitates the work activities of others. May provide technical guidance and training to others. Typically has team leader responsibilities. Proposes improvements to processes and may be responsible for quality execution of a process or analysis.

Exercises sound judgment within defined practices and policies for obtaining solutions, including facilitating any discussions that are required to resolve open issues. Ensures all product release occur in a timely manner and performs the necessary follow-up to prevent any conflicts or delays to business goals.
• Monitors and plans daily workload in the most efficient/productive manner
• Provides guidance to Manufacturing associates to ensure adherence to Quality System Procedures as needed
• Communicates the need for standards and process compliance to members of functional area. Bring standard and compliance questions/issues to the attention of next level management

• Effectively collaborates with functional group. Promotes a teamwork environment by partnering with peers and functional group.
• Communicates issues related to lack of resources to managers in a proactive manner
• Initiates Nonconforming Material reports and/or Planned Deviations as needed
• Participates in and contributes to continuous improvement initiatives. Works in collaboration with other functional departments in driving continuous improvement or implementing corrective action plans
• Prepares and distributes Quality Metrics related to the result of final inspection
• Acts objectively in solving problems
• Keeps manager informed of important changes/issues affecting Finished Product release or quality issues arising from the Mfg floor
• Work cross-functionally to expedite urgent batches to FGI.
• Review and write procedures and SOP’s. Initiate ECRs as needed.
• Assist in troubleshooting inspection process-oriented problems.
• Assist in the development and evaluation of new processes and procedures. Analyzes existing processes and procedures to suggest continual improvements.
• Follows BD Biosciences Environmental, Health and Safety (EH&S) policies and procedures. Takes responsibility for safety in immediate work area. Participates in EH&S programs. Notifies supervisors of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment.
• Supports internal customers: Operations, R&D, Production Planning, Quality Engineers, and Logistics.
• Performs other related duties and assignments as required.
 

Education and Experience:
Minimum Level of Education:
High school diploma
 

Experience:
• Daily working knowledge of SAP. Computer skills required, such as Microsoft Word, Microsoft Excel and the use of email.
• Pharmaceutical, Biotech, Medical Device, Regulatory, or QA experience preferred.
• Limited / Basic application of Quality systems principles and concepts ( e.g. Document control, Complaint Mgt or other broad Quality Systems area).
• Basic knowledge of ISO 9001, ISO 13485, and other applicable regulatory bodies.
• Limited/Basic application of Quality Systems principles and applicable Regulatory and/or Business requirements

Knowledge and Skills:
Self-driven and detail oriented. Able to work independently and with minimal supervision. Demonstrated ability to perform detail-oriented work with high degree of accuracy.
Effective time management skills. Ability to handle multiple tasks and meet deadlines.
Effective organization, planning, and prioritization skills.
Effective analytical and problem-solving skills.
Effective written and oral communication skills. Effective interpersonal skills.
Demonstrated ability to follow established policies and procedures.

Physical Demands: (if applicable)
Must be able to lift 35 pounds.
Must be able to work in different temperature environments (Ambient, 4C, -20C, -80C).
Work Environment: (if applicable)
Local drive or transportation may be required between different BD Biosciences San Diego facilities.