About PSC Biotech
Who are we?
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.
Overview:
The main purpose of the QC Analytical Data Reviewer manages, organizes, coordinates and controls the Laboratory Documentation review, training of analysts for QC Laboratory to attain the most effective and efficient deployment of human and material resources within a given budget respecting relevant due dates. This must be achieved through efficiency both in time and material resources, while ensuring compliance with GxP, company procedures, ALCOA+ requirements, most common regulations/guidelines, and best practices as well as Pharmacopoeia standards.
Responsibilities:
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Review routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
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Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
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Review laboratory test data and perform appropriate analyses.
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Verify documentation needed to support testing procedures, including data capture forms, equipment logbooks, or inventory forms.
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Evaluate the status of calibration of laboratory equipment.
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Participate in OOS/OOT/LIR and failure investigations and recommend CAPAs.
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Support development of data necessary for regulatory submissions.
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Investigate or report questionable test results.
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Review data of transfers of analytical methods in accordance with applicable policies or guidelines.
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Identify quality problems and recommend solutions.
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Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
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Train other analysts to perform relevant analysis according to laboratory procedures and best practices.
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Identify and escalate equipment problems.
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Participate in internal assessments and audits as required.
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Evaluate analytical methods and procedures to determine how they might be improved.
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Write technical reports or documentation, such as deviation reports, testing protocols, and trend analyses.
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Review data from contract laboratories to ensure accuracy and regulatory compliance.
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Serve as a technical liaison between quality control and other departments, vendors, or contractors.
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Coordinate testing with contract laboratories and vendors.
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Write or revise standard quality control operating procedures.
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Prepare or review required method transfer documentation including technical transfer protocols or reports.
Competencies:
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Strong experience as Analytical Lab Analyst in QC company manufacturing finished product working in GxP.
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2-3 years of analytical methodologies and instrumentation experince (UPCL, HPLC, GC, potentiometric titration, particle size, IR, UV etc.).
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Have in-depth knowledge of Chromatography Data Software Empower.
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Have in-depth knowledge of transfers of analytical methods.
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Have a strong experience in data integrity management (ALCOA+), Current Good Manufacturing Practices (cGMP), FDA guidelines, and other regulatory requirements.
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Proactive attitude towards work and learning new techniques.
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Good time management skills.
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Good organizational skills.
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Ability to work in a team.
Qualifications:
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Master’s degree in chemistry or similar Science degree.
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Excellent communication, troubleshooting and function skills.
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Proficiency using MS Word and QC Lab software/applications.
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Demonstrated mathematical and statistical skills.
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Ability to communicate clearly and fluency in English, both orally and in writing.
Physical Demands:
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Health & Safety requirements (e.g. Manual Handling Training).
- Contract Duration: 12 Months
