Job Description 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 cloud-based 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 like-minded 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 diverse-cultural work setting.
Employee Value Proposition Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house 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.
The Laboratory Analyst has responsibility for Raw Material, Intermediate and Drug Substance testing to meet compliance requirements and customer targets.
The Analyst may also take a leadership role in change or improvement projects at site level.
Requirements The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP.
The Laboratory Analyst assures compliance with all safety and environmental requirements.
Compliance with other regulated areas such as HR policies are also responsibilities of the role.
To test Raw Materials, Intermediates, Drug Substance, Drug products in accordance with Quality Standard and/or other approved protocols.
To comply with all GMP and analytical procedures relevant to area of work.
To adhere and comply with department High Performance Analytical Behaviours To document all testing activities and to input results into computerised lab systems in accordance with department and our Manufacturing Division standards.
To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
Complete the investigation of laboratory OOSs in line with site and divisional procedures.
Complete documentation checks (e.g.
PCR's, ACRs, Deviations) as required for the Drug Substance/Drug Product test package prior to release.
To complete testing as required on samples to support process changes.
Accountable for own laboratory safety practices.
To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
Provide leadership in the laboratory aspects of OOS investigations.
To identify and aid resolution of analytical issues within the IPT laboratory.
To be a resource for analytical testing for the site as required.
Execute specific assignments (e.g.
stability programme, instrument management and other systems) in a comprehensive manner and under minimum supervision.
Experience, Knowledge & Skills: Have knowledge of GMP standards Have knowledge Laboratory safety standards.
Must have good communication skills, both written and verbal.
Strong documentation skills are required.
Must be motivated, focused and technically strong.
To perform analytical testing with a high degree of precision and accuracy To perform instrument maintenance and troubleshooting To maintain accurate records in compliance with GMP expectations To understand and internalise procedures relevant to GMP operations.
To communicate clearly and concisely on technical issues On assignment, to deliver project goals on time.
Analytical chemistry – demonstrated ability in all technical elements relevant to ADC IPT operation.
Technical lab skills (precision, etc) Communication - written, oral Team and interpersonal skills Leadership skills Qualifications & Education: Minimum of BSc in Chemistry or related discipline #LI-PM3 Requirements • To perform analytical testing with a high degree of precision and accuracy • To perform instrument maintenance and troubleshooting • To maintain accurate records in compliance with GMP expectations • To understand and internalise procedures relevant to GMP operations.
• To communicate clearly and concisely on technical issues • On assignment, to deliver project goals on time.
• Analytical chemistry – demonstrated ability in all technical elements relevant to ADC IPT operation.
• Technical lab skills (precision, etc) • Communication - written, oral
