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. QC BioAnalytical Sciences MUST haves: Cell based potency bioassays min experience, Cell culture, GMP/GDP Elisa This job specification outlines the general responsibilities associated with the role of QC BioAnalytical Sciences – Senior Associate on the **** 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 liquid-handling robots is also preferable.
Plan and perform multiple, complex routine/ non-routine 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 Non-Conformance procedures.
Participate in the generation and update of SOP's, trend data, investigations, non-conformances, 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.
#LI-XA1 Requirements Knowledge/Skills: Strong Project Management and organizational skills, including ability to follow assignments through to completion.
Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills.
Escalate issues professionally and in a timely manner.
Ensures compliance within regulatory environment.
Demonstrated ability to work independently and deliver right first-time results under minimal direction.
Experience participating in and leading cross-functional teams.
Experience in managing multiple, competing priorities in a fast-paced environment.
Relevant Experience: Bachelor's degree in a Science or Engineering discipline.
3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage.
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