QC BioAnalytical Sciences
QC BioAnalytical Sciences
Posted on :
06-11-2024
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
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 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.
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 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.
#LIXA1
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. #LI-XA1
Employment Type
Full Time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
