Planning & Scheduling Specialist

Jobtailor; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a quality and compliance professional to support GMP regulated pharmaceutical/biotech environments in New Jersey. You will own deviation management, change control, CAPA, and SOP/documentation processes to maintain inspection readiness and robust operations.

Collaborating across functions, you will drive risk assessments, support audits and inspections, and contribute to continuous improvement, EHS activities, and system reliability while ensuring accurate technical

Qualifications

• Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, or related field.
• Several years of experience in GMP-regulated pharmaceutical/biotech/clinical manufacturing.
• Hands-on experience in deviation management, change control, CAPA, and SOP/documentation.
• Fluent in English, written and spoken.

Responsibilities

• Own and coordinate deviation records, supporting timely investigations and effective CAPA implementation.
• Support and monitor change control activities to ensure compliant and efficient implementation of process and system changes.
• Create, maintain and improve Standard Operating Procedures (SOPs) and Good Manufacturing Process (GMP) documentation that support robust and inspection-ready operations.
• Execute calibration, validation and qualification activities for equipment and systems in accordance with approved standards and procedures.
• Investigate technical issues, perform root-cause analyses and help implement sustainable corrective actions.
• Perform quality risk assessments to support sound decision-making and maintain a high level of compliance.
• Partner with cross-functional stakeholders to support audits, inspections and ongoing readiness activities.
• Contribute to improvement projects that enhance compliance, system performance and operational efficiency.
• Support Environmental Health & Safety activities, including Management of Change, where applicable.
• Ensure accurate, complete and timely technical and quality documentation across assigned responsibilities.

Skills

Deviation Management

Change Control

CAPA Management

GMP Compliance

Quality Risk Assessment

SOP Documentation

Calibration Activities

Validation Activities

Qualification Activities

Technical Problem-Solving

Collaborative Mindset

Effective Communication

Education

Life Sciences / Engineering / Pharmacy degree

Job description

• Own and coordinate deviation records, supporting timely investigations and effective CAPA implementation
• Support and monitor change control activities to ensure compliant and efficient implementation of process and system changes
• Create, maintain and improve Standard Operating Procedures (SOPs) and Good Manufacturing Process (GMP) documentation that support robust and inspection-ready operations
• Execute calibration, validation and qualification activities for equipment and systems in accordance with approved standards and procedures
• Investigate technical issues, perform root-cause analyses and help implement sustainable corrective actions
• Perform quality risk assessments to support sound decision-making and maintain a high level of compliance
• Partner with cross-functional stakeholders to support audits, inspections and ongoing readiness activities
• Contribute to improvement projects that enhance compliance, system performance and operational efficiency
• Support Environmental Health & Safety activities, including Management of Change, where applicable
• Ensure accurate, complete and timely technical and quality documentation across assigned responsibilities

Requirements

• Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, or a related field preferred
• Several years of experience in a GMP-regulated pharmaceutical, biotechnology, or clinical manufacturing environment
• Hands‑on experience in deviation management, change control, CAPA management and SOP/documentation processes
• Practical knowledge of calibration, validation and qualification activities for equipment and systems
• Strong technical problem‑solving skills with the ability to work independently and make sound decisions within established procedures
• Solid understanding of GMP requirements and quality risk management principles
• A collaborative mindset and the ability to work effectively across functions and with diverse stakeholders
• Fluent in English, written and spoken; additional language skills are an advantage

Core Competencies

Demonstrates expertise in deviation management, change control, and CAPA implementation within GMP‑regulated environments. Proficient in creating and maintaining SOPs and conducting quality risk assessments to ensure compliance and operational efficiency.

Highest-signal resume keywords

• Deviation Management
• Change Control
• CAPA Management
• GMP Compliance
• Quality Risk Assessment

ATS Optimization Keywords

Hard Skills

• Calibration Activities
• Validation Activities
• Qualification Activities
• Technical Problem‑Solving
• SOP Documentation

Soft Skills

• Collaborative Mindset
• Effective Communication

Industry Keywords

• Good Manufacturing Process
• Pharmaceutical
• Biotechnology
• Clinical Manufacturing
• Environmental Health & Safety