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Johnson & Johnson Innovative Medicine · 1 day ago

Senior QA Specialist, Compliance

Wilson, NC

Full-time

Onsite

Mid, Senior Level

$94K/yr - $152K/yr

6+ years exp

Johnson & Johnson is a leader in healthcare innovation dedicated to improving health for humanity. The Senior QA Specialist, Compliance is responsible for ensuring compliance with regulatory requirements and company policies, executing risk management programs, and collaborating with cross-functional teams to address quality issues.

Pharmaceuticals

Responsibilities

Responsible for execution of Risk Management Program through the identification, assessment, and management of quality risks. Implement appropriate preventive measures and corrective actions to minimize potential quality issues

Implement and execute the Notification to Management/Escalation procedures as defined by J&J standards and procedures. Facilitate timely resolution through coordination with relevant department and teams

Responsible for development and implementation of Data Integrity Program for the BioNC site in alignment with J&J standards and procedures

Responsible for preparation, review and submission of data reported to Health Authorities including BPDRs, Inspection responses and review of Regulatory submission documents

Collaborates and contributes to Site Inspection Readiness Activities, including global internal audits and assessments

Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues

Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance

Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards

Partners with other Departments to ensure that compliance systems are implemented in an efficient manner

Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site

Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS)

Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site

Qualification

Manufacturing Practices (GMP)Regulatory inspectionsRisk management methodologiesQuality Management Systems (QMS)ISO standardsContinuous ImprovementCommunicationProblem Solving

Required

Bachelor's degree in a scientific or engineering discipline is required

Minimum six (6) years experience working within the biological and/or pharmaceutical industry in a quality, manufacturing, or compliance role

Strong knowledge of relevant regulations and quality management principles, such as Good Manufacturing Practices (GMP), ICH, and ISO standards

Understanding and experience in application of global regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment

Experience with regulatory inspections and response to observations

Proficiency in risk management methodologies such as FMEA

An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements

Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams

Proven ability to manage multiple priorities and work independently with minimal supervision

Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements

Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment

Ability to build and nurture strong and positive relationships. The ability to work in a team environment and interact with all levels of the organization

Preferred

Business Alignment

Business Savvy

Coaching

Communication

Compliance Management

Continuous Improvement

Fact-Based Decision Making

Human-Centered Design

ISO 9001

Issue Escalation

Problem Solving

Quality Control (QC)

Quality Management Systems (QMS)

Quality Standards

Regulatory Environment

Standard Operating Procedure (SOP)

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year