QC Senior Associate

About PSC Biotech

Who we are

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 cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

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 the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

QC Senior Associate

Overview:

QC Systems Senior Associate Investigations is a key member of the QC Systems team. They provide support to the QC function for all activities within client Quality System associated with QC Deviation Investigations CAPA records Analytical Results Assessments (ARA) and Change Controls.

The successful candidate will own and manage the endtoend life cycle of Quality records on behalf of Quality Control. The role has a strong focus on technical writing and problemsolving including Root Cause Analysis and 5 Why methodologies.

The role may involve carrying out additional work functions that are not described in this specification but are required as per business needs.

Requirements

Specific Duties/ Scope:

Triage Management

Quality Record owner

Technical writing for investigations

Ensure timely closure of Quality Records

SME for Root Cause Analysis and 5 Why methodologies

Development of robust CAPA and CAPA Effectiveness Verification in conjunction with area SMEs

Trend Analysis of QC Quality records

Monthly Metrics Management and Reporting

Participate in cross functional Investigations Teams

Lead Continuous Improvement Initiatives

Contribute to success of QC Goals

Support NPI/ Lot Release / Stability linked to Quality Records

Participate in Regulatory Inspections

Ownership of Change Controls Key Values and Competencies:

Work in Teams; Ensure Quality; Be Science Based; Collaborate Communicate and Be Accountable

Ability to work through Complex Problems

Excellent verbal and written communication skills including technical writing presentation and facilitation skills.

Ability to work in a fastpaced environment with changing priorities.

Comfortable working under minimal direction Knowledge and Experience

Hold a third level qualification in a science related discipline.

Have a minimum of 4 years experience in Biopharmaceutical/ Pharmaceutical industries or 2 years in a similar investigator role.

Experience owning Quality Records e.g. Deviation Records CAPA ARA and Change Controls advantageous.

Possess key competencies to include planning/organization problem solving excellent verbal and written communication teamwork flexibility and adaptability.