QA Specialist (Biotechnology Industry) 3564068

ProQuality Network; United States; Hybrid; USD 70,000 - 100,000; Full time

Job summary

ProQuality Network is seeking a Quality Assurance Specialist to support a client in the biotechnology industry. You will ensure compliance with cGMP/cGLP, review records, and oversee QA activities across manufacturing operations.

The role involves leading investigations, change controls, CAPA, and continuous improvement initiatives, with collaboration across cross-functional teams and audits. This is a contract position (~6 months).

Qualifications

• QA practitioner with biotech or pharmaceutical industry exposure.
• Experience with quality systems, deviations, CAPA and change control.
• Familiarity with validation, CSV, and regulatory expectations.

Responsibilities

• Perform QA disposition for bulk drug substances.
• Oversee cGMP/cGLP compliance across manufacturing, testing, storage, and distribution.
• Evaluate change controls and conduct incident triage as needed.
• Review records and test results for accuracy and compliance.
• Lead continuous improvement and site quality initiatives.
• Support internal/external audits and QA representation.

Skills

Quality Systems

CAPA

Deviations

Change Control

GxP

Regulatory Agencies

NPI

CSV

TrackWise

LIMS

SAP

QA Validation

Education

Master’s + 2 years of relevant experience

Bachelor’s + 4 years of relevant experience

Associate’s + 8 years of relevant experience

High School Diploma/GED + 10 years of relevant experience

Tools

CDOCS

LIMS

MES

SAP

Job description

QA Specialist (Biotechnology Industry) 3564068

Specialist QA (Biotechnology Industry)

Job ID: 35464068

Shift: Non-Standard Shift

Position Type: Contract (Approx. 6 months)

Openings: 1

Employer: ProQuality Network (supporting our client)

Overview

We are seeking a Quality Assurance Specialist to support our client’s Quality Assurance program within the biotechnology industry. This role operates with minimal supervision and plays a critical part in ensuring compliance, product quality, and regulatory excellence across manufacturing operations.

Key Responsibilities

• Perform Quality disposition (approval or rejection) of bulk drug substances
• Provide QA oversight to ensure manufacturing, testing, storage, and distribution comply with:
• cGMP (Current Good Manufacturing Practices)
• cGLP (Current Good Laboratory Practices)
• Applicable regulatory requirements
• Identify, document, and ensure proper handling of deviations
• Evaluate and assess change controls that may impact product quality
• Review production records and test results for accuracy, completeness, and compliance
• Ensure alignment of:
• Facilities
• Equipment
• Materials
• Processes and procedures
• with regulatory expectations
• Lead and support continuous improvement initiatives
• Maintain compliance with training requirements
• Collaborate cross-functionally to ensure Quality Management System (QMS) processes are executed effectively
• Support internal and external audits/inspections, acting as QA representative when needed
• Escalate risks related to quality, compliance, safety, or supply to senior management
• Provide QA oversight for New Product Introduction (NPI) activities

Core Functions

• Review and approve Master Production Records (MPs)
• Approve process validation protocols and reports
• Participate in incident triage teams
• Review and approve:
• Planned incidents
• Work orders
• Support sanitary utility system release
• Represent QA in NPI teams
• Lead:
• Investigations
• Own and manage site quality procedures
• Act as QA designee in Change Control Review Board (CCRB)
• Review risk assessments
• Support automation, facilities, and environmental programs
• Approve:
• Non-conformance investigations
• CAPA records
• Change controls
• Perform lot disposition and authorize product release

Preferred Qualifications

• Background in Life Sciences, Engineering, or related field
• Strong expertise in Quality Systems, including:
• Deviations / Non-conformances
• CAPA
• Change Control
• Experience with systems such as:
• CDOCS
• TrackWise
• LIMS
• MES / Electronic Batch Records
• SAP
• Experience in Computer Systems Validation (CSV) or Computer Systems QA
• Knowledge of GxP systems validation, including:
• Validation Master Plans
• IQ/OQ/PQ protocols
• Test scripts and validation reports
• Strong understanding of manufacturing, QA, QC, and process development operations
• Experience supporting complex projects (NPI, packaging, inspection, commissioning, qualification)
• Proven ability to interact with regulatory agencies
• Fully bilingual (English & Spanish)

Education Requirements

• Master’s + 2 years of relevant experience OR
• Bachelor’s + 4 years of relevant experience OR
• Associate’s + 8 years of relevant experience OR
• High School Diploma/GED + 10 years of relevant experience
• Strong project management and organizational skills
• Ability to lead and collaborate with cross-functional teams
• Excellent problem-solving, influencing, and negotiation skills
• Advanced knowledge of:
• QA systems
• Validation processes
• Manufacturing and distribution operations
• Strong data analysis and trending capabilities
• Excellent written and verbal communication skills
• Ability to work independently and across all organizational levels
• Proficiency in:
• Word processing
• Spreadsheets
• Presentations
• Ability to assess and manage compliance risks effectively