Cel – Qa Associate

ACS group has an immediate need for a “QA ASSOCIATE” with experience in the Pharmaceutical Industry. This is a 06- month contract opportunity in Bothell, WA. Our client is a leading Pharmaceutical company.

Please review the job description below:

Top Skills:

• Pharmaceutical
• Quality Assurance
• Deviation
• quality systems
• CAPA

Key Requirements and Technology Experience:

Shift: Sunday – Wednesday, 10 am – 8:30 pm, reports into the QSAT Deviation Facilitator Lead

Shift: Wednesday – Saturday, 10 am – 8:30 pm, reports into the QSAT Deviation Facilitator Lead

PURPOSE AND SCOPE OF POSITION:

The QSAT (Quality Science and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. This position will be responsible for operating cross-functionally and facilitating the timely approval and closure of deviation records (excluding Major and Critical deviations).

This person will be a key player in the JuMP Quality Assurance team and a champion for quality priority principles and compliance within the JuMP organization.

Education:

Minimum of Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.

Experience * 2+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.

Minimum of 1 years working within quality systems managing deviation and CAPA records.

Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.

Knowledge, Skills, and Abilities

Experience in GMP compliance and FDA/EMA regulations.

Demonstrate excellence in written and verbal communication.

Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

Innovative, proactive, and resourceful; committed to quality and continuous improvement.

Ability to anticipate and mitigate challenges.

DUTIES AND RESPONSIBILITIES: Key Responsibilities

Builds processes to approve and close NOEs by the end of the shift (95% within 24 hours)

Builds and manages a real-time process to establish feedback to departments on preventable deviations for awareness and documentation.

Collaborates with stakeholders to develop mitigation plan to prevent reoccurrence.

Establishes system for providing feedback to initiators to continue to drive RFT

Establishes targets for turnaround times for requests from Investigators and QA Reviewers / Approvers to Operations

Point of contact for all deviations in all departments at the point of observation and/or discovery

Follows the classification decision tree and procedures to determine initial assessment for classification (batch comment, NOE, minor / major, critical), escalates real-time when needed to ensure real-time classifications are made

Completes the QA Assessment by the end of the shift (no later than 24 hours from the original observation of the event) for all NOEs, acts as deviation facilitator for all functional areas as needed.

Ensures IDAs and QA Assessments are completed in a timely manner, acts as deviation facilitator for all functional areas as needed

Identifies owners for IDAs, QA Assessments, and Investigations

Assesses impacted lots and materials accurately, references CAPA as needed

Point of contact for the Investigators and QA Reviewers / Approvers when further information or clarification is needed

Coaches the area owner on initiation of the deviation in the deviation system

Coaches the area owner on completion of the IDA for NOEs

Provides timely, complete and accurate information

Helps bridge communication and relationships between QA Ops OTF and QSAT

Ensures timely delivery and documentation of deviation feedback to operations (RFT, preventable deviations, trends, etc)

Uses both soft-skills and technical skills to drive the deviation and CAPA processes:

demonstrates good teamwork, collaboration, and communication skills with all internal and external customers

Seeks to understand, demonstrates humility, and shows curiosity for learning

Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase

Understands appropriate assignment of classifications and requirements for each

Thanks & Regards
Parag PATEL

Team Recruitment

P: (+1) 678 487 8366

ABOUT ACS GROUP. – ACS Group is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions tFortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies:
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