Quality Control Snr Associate

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 points 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.

Quality Control Snr Associate

Job Summary:

Under minimal supervision responsible for one or more of the following activities in QC including analytical testing characterization sample and data management.

Contributes to team by ensuring the quality of the tasks/services provided by self

Contributes to the completion of milestones associated with specific projects or activities within team.

This role will support QC and manufacturing operations as such some extended hours and weekend work flexibility may be necessary as required.

Requirements

Primary Responsibilities:

QC Representative for NPI activities and routine Product meetings

Assist with activities related to QC projects and/or QC tasks within Site projects.

Plan and perform noncore testing related to NPI activities.

Manage all sample management activities related to NPI activities throughout the site.

Create/own and approve protocols sample plans SOP and documentation related to NPI.

QC Representative responsible for Method Validation and Transfers coordination and readiness

Responsible for their own training and safety compliance.

Sample shipments and temperature monitoring activities for NPI activities.

LIMS data coordination of noncore (NPI) activities.

Specific Job Duties:

With a high degree of technical flexibility work across diverse areas within QC

Plan and perform analyses with great efficiency and accuracy.

Plan and perform multiple complex routine/ nonroutine methods and procedures and a large variety of assays.

Report evaluate backup/archive trend and approve analytical data.

Troubleshoot solve problems and communicate with stakeholders.

Initiate and/or implement changes in controlled documents.

May train others as necessary

Participate in audits initiatives and projects that may be departmental or organizational in scope.

Write protocols and perform assay validation and equipment qualification/ verification.

Introduce new techniques to the lab including method transfers reports validations and protocols.

May contribute to regulatory filings.

May conduct lab investigations as necessary.

Evaluate lab practices for compliance on a continuous basis.

Approve lab results.

May represent the department/organization on various teams.

May interact with outside resources.

Create APPX data files and randomisation memo to facilitate data analysis.

LIMS data coordination of commercial and import testing on site where applicable.

May provide technical guidance. May contribute to regulatory filings.

May represent the department/organization on various teams. May train others.

May interact with outside resources.

Basic Qualifications & Experience:

Qualifications:

Bachelor s degree in a science discipline.

23 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

Strong background in Chemistry and Analytical testing is required.

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Knowledge:

Understanding and application of principles concepts theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning.

Knowledge of related regulatory/industry considerations compliance issues and/or scientific discovery

Problem Solving:

Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information.

Qualitative information

Quantitative research

Trend data

Anticipates and prevents potential problems.

Skills:

Take initiative to identify and drive improvements.

Communication skills (verbal and written) at all levels.

Strong Technical writing skills for GMP documentation (e.g. investigations procedures change controls)

Presentation skills

Escalate issues professionally and on a timely basis.

Decision making

Teamwork and Coaching others

Teamwork and Coaching others

Auditing documentation and operation process

Competencies:

Demonstrated ability to work independently and deliver right firsttime results

Works under minimal direction

Work is guided by objectives of the department or assignment.

Follows procedures.

Refers to technical standards principles theories and precedents as needed.

May set project timeframes and priorities based on project objectives and ongoing assignments.

Recognizes and escalates problems.

Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues.

Auditing documentation and operation process

Demonstrated ability to interact with regulatory agencies.

Relevant experience:

Bachelor s degree in a Science related field is required.

5 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

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