Senior QC 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 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 qualification of a new production facility by writing qualification documents, SOPs, trend reports etc. The current expectation is to work days, however there may be a request to go on shift at a later date in order to support performance qualification of the new facility.

Specific Job Duties:

Lead QC Technical documentation projects as an individual contributor.

Accountable for timely completion of projects within the technical writing role.

Collaborate with internal resources and business partners to support project requirements and ensure project completion.

Work in accordance with cGMP and GLP requirements.

Ensure consistent and good documentation practices are followed.

Creation, review, and update of documentation, e.g. Laboratory Technical Protocols and Reports, Standard Operating Procedures, and Analytical Protocols.

Translating complex topics into clear, concise, and understandable topics is required.

Review standards for documentation types, structure, and assembly so that content is organised logically with the end reader in mind.

Maintain Documents in the document management system.

Additional tasks:

Support QC Specialist with risk assessments/procedures for new facility

Working with the project team to ensure we have sufficient resources and equipment for the project

Completing qualification works for the new isolator, media qualification etc

Reading & review of EM plates

Execution of EM PQ of new facility

Requirements

Basic Qualifications:

Bachelors degree in a science discipline

Biopharmaceutical QC experience in Environmental Monitoring

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

Experience in technical writing

Preferred Qualifications:

Experience working in an aseptic cleanroom

Proficient in the use of LIMS & LMES

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

Good cross functional communication skills are essential

Presentation skills

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-KV1

Basic Qualifications: Bachelors degree in a science discipline Biopharmaceutical QC experience in Environmental Monitoring Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products Experience in technical writing Preferred Qualifications: Experience working in an aseptic cleanroom Proficient in the use of LIMS & LMES 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 Good cross functional communication skills are essential Presentation skills 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-KV1