Associate Quality Specialist

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.

Position Summary

• The Contract Associate Quality Specialist is responsible
  for supporting day-to-day Quality Assurance activities at the facility and
  serves as an integral member of the Quality Systems Centre of Excellence (CoE)
  Team. This role ensures robust compliance with global quality and cGMP
  standards, supports core site quality systems, and actively contributes to
  continual improvement initiatives across the site.
  
• Operating within a fast-paced environment, the successful
  candidate will apply strong quality systems knowledge to oversee quality
  agreement management, support supplier qualifications, manage customer
  complaints, and drive thorough root cause identification for deviations, CAPAs,
  and validation lifecycle activities. Additionally, this role provides critical
  QA oversight for analytical and microbiological laboratory operations,
  equipment/method validation, environmental monitoring compliance, and material
  shelf-life/expiry evaluations.
  
• 11 Month of Contract
  

Requirements

Key Responsibilities

Quality Systems, Investigations & CAPA

• Deviation Trending & Support: Provide quality
  assurance oversight for deviation investigations, process performance
  monitoring, and root-cause analysis. Perform routine deviation trending to
  identify systemic patterns and drive proactive site improvement initiatives.
  
• CAPA Management: Apply robust knowledge of quality
  systems to ensure the definition and execution of highly effective Corrective
  and Preventive Actions (CAPA).
  
• Customer Complaint Management: Coordinate, track,
  and support the investigation of customer complaints. Collaborate with
  cross-functional technical teams to perform thorough impact assessments,
  establish root causes, and draft technical complaint investigation reports in a
  timely manner.
  

• Annual Reviews: Coordinate and prepare Annual
  Product, Process, and System Reviews to verify ongoing validation status and
  regulatory compliance.
  

Analytical & Microbiological QA Support

• Analytical Support & Change Control: Act as
  the primary QA compliance partner for site analytical and microbiological
  laboratories. Review, technically assess, and approve laboratory change
  controls, including updates to testing specifications, laboratory
  instrumentation, software parameters, and reagents.
  
• Method Validation & Approval: Review, assess,
  and approve analytical and microbiological method validation, verification,
  co-validation, and transfer protocols and reports (e.g., for HPLC, GC, wet
  chemistry, physical testing, and microbiological assays) to ensure compliance
  with global regulatory filings, USP/EP/JP compendial requirements, and ICH Q2
  guidelines.
  
• Environmental Monitoring (EM) & Micro Oversight: Provide Quality Assurance oversight for the site’s Environmental Monitoring,
  microbiological control. Review EM data trends, support the investigation of
  cleanroom environmental or utility out-of-limit/out-of-trend (OOT) events, and
  participate in aseptic qualification activities, media fills, and contamination
  control assessments.
  

• Material Expiry & Retest Evaluation: Evaluate
  raw material, intermediate, and API stability data to support material expiry
  extension or retest date recalculation requests. Ensure all material expiry
  evaluations are scientifically justified, fully documented, and compliant with
  site regulatory files.
  
• 
  

• Agreement Management: Act as the dedicated site
  coordinator for Quality Agreements (QAs) and Change Agreements (CAs).
  
• Oversight & Maintenance: Maintain and oversee
  the site's QA and CA registers, execute periodic reviews of active agreements,
  and author or revise agreements as regulatory or business needs dictate.
  
• Supplier Qualification Support: Support the site's
  Supplier Qualification program. Help manage the approved vendor register,
  evaluate supplier assessment questionnaires, draft supplier quality agreements,
  and coordinate risk assessments for new or modified materials and service
  providers.
  

SAP Master Data & Governance

• Data Stewardship: Support SAP Master Data
  creation, standard updates, and strict data governance activities to maintain
  operational compliance and system integrity.
  

• Inventory Status & Expiry Control: Partner
  with warehouse and supply chain teams to govern material status changes, expiry
  date updates, and quarantine locks within SAP following material expiry
  evaluations.
  
• 
  

• Equipment Validation Oversight: Provide Quality
  Assurance oversight, review, and approval for equipment, utility, and facility
  qualification/validation activities. Evaluate and approve IQ/OQ/PQ protocols,
  validation execution data, and final reports (utilizing electronic validation
  systems such as Kneat and ProCal) to ensure compliance with cGMP and data
  integrity principles.
  
• Submission Support: Support regulatory
  submissions, market renewals, and GMP declarations by compiling, reviewing, and
  providing timely and accurate Quality Assurance inputs.
  

• Validation Guidance: Provide QA guidance on
  compliance requirements to maintain validated status across systems and
  processes, including active participation in product and process risk
  assessments.
  
• 
  

• Lead/Support Audits: Act as a lead or team auditor
  for internal GMP walkdowns and scheduled site audits to maintain inspection
  readiness.
  
• Metrics & Reporting: Support the development,
  compilation, and critical analysis of key site quality metrics. Draft
  compliance summaries and prepare reporting materials for site Quality Councils
  and cross-functional leadership teams.
  

Qualifications & Skills

Education

• Degree or postgraduate qualification in Chemistry,
  Microbiology, Biology, Science, Pharmacy, Engineering, or a related technical
  discipline.
  

Experience & Technical Knowledge

• Industry Experience: (3+) years of Quality Assurance,
  Quality Systems, or Laboratory QC/Microbiology experience in a highly regulated
  GxP pharmaceutical or biopharmaceutical manufacturing environment.
  
• Laboratory & Microbiology Compliance: Direct
  experience reviewing analytical/microbiological laboratory investigations
  (OOS/OOT), laboratory change controls, stability protocols, environmental
  monitoring data, or sterility assurance parameters.
  
• Method Validation Expertise: Demonstrated,
  practical knowledge of method validation, verification, and transfer principles
  (e.g., executing or reviewing protocols in line with ICH validation
  parameters).
  
• Environmental Monitoring: Practical knowledge of,
  microbiological testing methodologies (e.g., bioburden, endotoxin, growth
  promotion), environmental monitoring programs.
  
• Equipment & Validation Knowledge: Practical
  exposure to reviewing equipment qualification protocols, change controls, or
  engineering validation packages (ideally utilizing systems like Kneat and
  ProCal).
  
• Core QA Competencies: Proven understanding of
  Quality Agreements, Change Agreements, Supplier Qualification practices,
  Customer Complaint handling, and SAP Master Data governance.
  
• Continuous Improvement: Demonstrated knowledge and
  practical application of Lean principles or Continuous Improvement
  methodologies (e.g., Kaizen, Six Sigma, Right-First-Time).
  

Core Competencies

• Communication: Demonstrates excellent written and
  verbal communication skills; possesses the ability to convey complex quality,
  microbiological, and technical validation concepts clearly, accurately, and
  appropriately across diverse operational, laboratory, and leadership audiences.
  
• Teamwork & Collaboration: Collaborates
  effectively within cross-functional teams to support Right-First-Time (RFT)
  performance across site operations; willingly shares knowledge and resources to
  support mutual goals.
  
• Decision Making: Exercises sound,
  compliance-driven judgment utilizing data-driven insights; makes well-informed
  decisions that balance compliance standards with operational requirements.
  
• Adaptability: Responds quickly and effectively to
  changing site priorities, regulatory landscapes, and project timelines;
  comfortable operating in a dynamic contract environment.
  
• Work Standards: Demonstrates an uncompromised
  commitment to high standards of accuracy, precision, and completeness with
  strong attention to detail.