QC Microbiology Shift

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 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.

Description:

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

• Shift Pattern:4 cycle (12 hour pattern days and nights including weekends)
  
  

Specific Job Duties:

Environmental Monitoring of Grade 8/9 Cleanrooms

Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators

Reading of Environmental Monitoring Plates

Bioburden testing of water & disinfectants

Writing technical reports

Water sampling

Testing of In Process samples such as Protein Concentration, Density & pH

Basic Qualifications:

Bachelors degree in a science discipline

Biopharmaceutical QC experience in a microbiology lab

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

Preferred Qualifications:

Experience working in an aseptic cleanroom performing Environmental Monitoring

Proficient in the use of LIMS & LMES

Requirements

Competencies:

Technically strong background in microbiology and aseptic manufacturing

Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage

Flexibility the EM role often encounters changing priorities on a daily basis

Problem solving skills

Experience with Regulatory inspectors and interacting with inspectors desirable

Demonstrated ability to work independently and deliver right first time 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

Demonstrated leadership and communication skills

Auditing documentation and operation process

Demonstrated ability to interact with regulatory agencies

#LI-DM1

Competencies: Technically strong background in microbiology and aseptic manufacturing Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage Flexibility the EM role often encounters changing priorities on a daily basis Problem solving skills Experience with Regulatory inspectors and interacting with inspectors desirable Demonstrated ability to work independently and deliver right first time 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 Demonstrated leadership and communication skills Auditing documentation and operation process Demonstrated ability to interact with regulatory agencies #LI-DM1