Quality Assurance
2 months ago
About PSC Biotech
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.
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.
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.
Senior Associate Quality Assurance
IMPORTANT: there is an eyesight test that they must pass before we can proceed with an offer.
Job Description:
- The Sr. Associate in Quality Assurance (QA) will be an active member of the **** QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components.
- The Sr. Associate in Quality Assurance will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr. Associates may be asked to carry out additional work functions to support site continuous improvement activities.
Key Responsibilities:
- Testing of primary and secondary components for use in the manufacture of aseptic products.
- Sampling of Excipients and Drug Substance under Grade C conditions.
- Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
- Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
- Provide training and advice to staff in relation to testing of components and packaging.
- Actively participate in audits and their preparation.
- Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation.
- Write, review and approve Standard Operating Procedures in accordance with **** Policies.
- Perform all activities in compliance with *** safety standards and SOPs.
- Support continuous improvement and Operational Excellence initiatives.
- Any other tasks/projects assigned as per manager’s request.
Requirements
Basic Qualifications & Experience:
- Must Pass Eye-Tests required for Visual Inspection
- University degree. Engineering or Science related discipline preferred
- Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications & Experience:
- Excellent written and verbal communication skills
- Experience working with dynamic cross-functional teams and proven abilities in decision making
- Strong organizational skills, including ability to follow assignments through to completion
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
Onsite Expectations:
- Expectations are to be onsite FIVE days a week and it’ll also be a shift role.
- We will have people coming in from 07:00 to 15:00, Monday to Thursday, 07:00 to 14:00 on a Friday.
- Late shift is from 14:30 to 10:30 Monday to Thursday, 13:30 to 08:30 on a Friday.
#LI-PM1
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