QA Downstream Operations Associate Specialist-Shift

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:

An amazing opportunity has arisen for a QA Downstream Operations Associate Specialist at our site.

Requirements

Job Purpose:

• The Quality Associate Specialist ensures adherence to Good Manufacturing and Documentation Practices Quality Manual and local procedures. The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance to enable documentation to be completed right the first time and to ensure compliance with cGMPs and regulatory requirements.
  
  

Role Functions:

• Provide direct Quality support to production and support areas.
  
• Provides presence on the shop floor to support compliance and data integrity.
  
• Review and approve GMP documentation/data for accuracy and completeness.
  
• Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
  
• QA support review and approval of C&Q Performance qualification (PQ) & Process Validation documents.
  
• Support sustaining activities such as change management deviations CAPAs equipment requalification periodic review site maintenance & Calibration Programs.
  
• Provides support to internal audits and regulatory inspections.
  
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
  
  

Experience Knowledge & Skills:

General competencies:

• Motivation to be an inspiring member of a high performing team.
  
• Desire to continuously learn improve and develop.
  
• Leadership skills coupled with good oral and written communication skills.
  
• Demonstrated interpersonal skills including flexibility collaboration and inclusion skills and ability to work/ upskill/coach a team environment.
  

Technical competencies:

• Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field.
  
• Technical writing skills.
  
• Lean Six-sigma and problem solving tools.
  

Qualifications & Education:

• Bachelor degree in a scientific or engineering field.
  
• 3 years of relevant post-degree experience in a GMP environment: manufacturing laboratory quality operations technical or regulatory function.
  

Shift Pattern: Shift will be 4 days on 4 days off with 12 Hour Shifts