QA Operations Specialist-Shift

Overview

Job Description

About PSC Biotech

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Who are we?

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with a talented cohort of professionals in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to work at top pharmaceutical client sites in a diverse cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech. We provide empowering career development through Learning & Development, in-house training and mentorship to facilitate career progression. We believe in creating high performing teams that exceed client expectations with regards to quality of deliverables, staying under budget and ensuring timelines are met.

Role Summary

The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to cGMP and Documentation Practices, and represents quality on the shop floor.

The Quality Specialist reviews process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support batch disposition activities for release of product and assist in investigations of deviations. The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance and to enable documentation to be completed right first time, ensuring compliance with cGMPs and regulatory requirements.

Shift Pattern: This is a shift role (4 x 12hr extended days followed by 4 days off).

Responsibilities

- Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
- Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures
- Provide presence on the shop floor to support compliance and data integrity
- Review and approve new and updated SOPs/Work Instructions and Controlled Job Aides
- Actively participate in the Tier process and use this forum to make issues visible and partner with the functional area on resolution
- QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment
- Serve as the Quality SME for Performance Qualification (PQ) activities across the site including Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation
- Participate as the quality member on cross-functional projects
- Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program
- Provide support to internal audits and regulatory inspections
- Collaborate with cross-functional team members in identifying and implementing continuous improvement initiatives and action plans
- Drive continuous improvement and utilize problem solving tools and participate in CI initiatives to enhance operational efficiency

Experience, Knowledge & Skills

Required

- Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment in Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function
- At least 5 years working knowledge in the biotech industry with QA operations and regulatory agency engagement considered an advantage
- Evidence of leadership skills with good oral and written communication
- Understanding of cGMPs and regulatory requirements in the pharmaceutical field or related area
- Interpersonal skills including flexibility, collaboration and inclusion and ability to work in a team

Preferred

- Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents
- Analytical aptitude, critical thinking and problem-solving skills
- Ability to upskill/coach others
- Experience working on the manufacturing shop floor
- Familiarity with GMP documentation review and/or shop-floor auditing

Qualifications & Education

- Bachelor degree in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered with significant relevant experience

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