QC Bioanalytical Science

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 point 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.

Job title: QC Bioanalytical Science

This job specification outlines the general responsibilities associated with the role of QC Bioanalytical Sciences Senior Associate on the client Manufacturing site. This role will be responsible for leading coordinating facilitating and undertaking activities pertaining to lab operations and compliance with minimal supervision acting as a role model for other lab colleagues. The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.

Additionally the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Requirements

Key Responsibilities:

Experience in a wide variety of analytical techniques including but not limited to cell based Bioassays Immunoassays Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquidhandling robots is also preferable.

Plan and perform multiple complex routine/ nonroutine methods and procedures and a large variety of assays.

Participate in the peer review of analytical data.

Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.

Lead training of staff on technical aspects of job as required.

Develop revise and implement procedures that comply with appropriate regulatory requirements.

Qualification of analytical equipment and related testing functions.

Participate in Analytical Method Transfers

Compliance with Standard Operating Procedures and Registered specifications.

Ensure the laboratory is operated in a safe manner.

Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.

Ensure timely completion of Laboratory Investigation Reports and deviations through the NonConformance procedures.

Participate in the generation and update of SOP s trend data investigations nonconformances validation protocols reports method validation/verifications and equipment qualifications.

Participate in regulatory agency inspections as required.

Plan and implement procedures and systems to maximise operating efficiency.

Manage and contribute to the achievements of department productivity and quality goals.