QA Associate II

Jobtailor; Malvern (Chester County); On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor in Malvern, PA seeks a qualified QA professional to oversee GMP manufacturing quality across operations. You will collaborate with QA and manufacturing teams to ensure compliance with FDA/EU guidance and drive CAPA projects.

The role emphasizes robust documentation, process improvement, and proactive quality culture. The ideal candidate has a strong background in regulated biotech/pharma environments, excellent communication, and the ability to operate independently within

Qualifications

• Bachelor's degree in a science/engineering field is required.
• At least 3 years of experience in a regulated manufacturing environment, preferably biotech/pharma.
• Ability to maintain written records in paper-based and computerized quality systems.
• Ability to work independently on routine tasks with supervision on complex issues.
• Strong communication, collaboration, and attention to detail.

Responsibilities

• Provide end-to-end quality oversight of GMP manufacturing areas.
• Liaise with internal quality groups to standardize policies and raise awareness of quality concerns.
• Partner with R&D and Supply Chain to support GMP manufacture of clinical products and materials.
• Collaborate with business partners on new product introductions.
• Perform periodic oversight of manufacturing areas and on-call support as needed.
• Review and approve controlled documents including SOPs, WIs, and risk assessments.
• Investigate non-conformances and implement effective CAPAs.
• Support change controls by evaluating proposed changes and advising on implementation.
• Perform batch record review and critical alarm review.
• Assist in process improvement and cross-functional project implementation.
• Support site inspections and readiness activities.

Skills

GMP Regulations

Quality Systems

Batch Record Review

Controlled Document Approval

Risk Assessment

Change Management

Non-Conformance Investigation

Phase Appropriate GMP Practices

Biotechnology Manufacturing

Pharmaceutical Manufacturing

Education

Bachelor’s Degree in Engineering/Biology/Biochemistry/Microbiology/Chemistry or relevant scientific field

Job description

• Provide end to end quality oversight of GMP manufacturing areas.
• Act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.
• Partner with Research & Development and Supply Chain teams to support GMP manufacture of clinical products, medias, and buffers.
• Collaborate with business partners to support new product introductions.
• Perform regularly scheduled oversight of manufacturing areas and on‑call support as assigned.
• Review and approve controlled documents including standard operating procedures, work instructions, and risk assessments.
• Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
• Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
• Perform batch record review and critical alarm review.
• Support in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
• Support site inspections and inspection readiness activities.
• Other duties may be assigned as necessary.

Requirements

• A minimum of a Bachelor’s Degree is required with a focus in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field preferred.
• At least 3 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
• Ability to maintain written records of work performed in paper-based and computerized quality systems.
• Ability to work independently on routine tasks and require some supervision on complex issues.
• Ability to be organized and capable of working in a team environment with a positive demeanor.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
• Working knowledge of cGMP regulations and FDA/EU guidance related to biologics and cell banking.
• Experience in Quality or Manufacturing for Large Molecule Manufacturing.
• Working knowledge of Phase Appropriate GMP practices.
• Experience with document reviews and regulatory inspection processes is preferred.
• Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities.

Demonstrates expertise in GMP manufacturing oversight, quality compliance, and regulatory standards, with a strong focus on process improvement and effective communication across teams. Proficient in managing documentation and change control processes while ensuring adherence to cGMP regulations and FDA/EU guidance.

Highest-signal resume keywords

• GMP Manufacturing Oversight
• Quality Compliance
• Document Review
• Regulatory Inspection Processes
• Process Improvement

ATS Optimization Keywords

Hard Skills

• GMP Regulations
• Quality Systems
• Batch Record Review
• Controlled Document Approval
• Risk Assessment
• Change Management
• Non-Conformance Investigation
• Phase Appropriate GMP Practices
• Biotechnology Manufacturing
• Pharmaceutical Manufacturing

Soft Skills

• Attention to Detail
• Interpersonal Communication
• Organizational Skills
• Team Collaboration
• Adaptability

Industry Keywords

• Biologics
• Cell Banking
• FDA Guidance
• EU Guidance
• Regulated Manufacturing