Johnson & Johnson · 2 days ago
Senior QA Specialist, Release
Wilson, North Carolina, United States of America
Full-time
Onsite
Mid, Senior Level
$94K/yr - $152K/yr
6+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to improving health outcomes. The Senior QA Specialist is responsible for ensuring compliance with regulatory requirements and company policies through quality assurance activities, including batch record review and collaboration with cross-functional teams to address quality issues.
Hospital & Health Care
Responsibilities
Responsible for Quality Assurance Batch Record Review and Approval for batch release, including Certificate of Analysis preparation, to ensure compliance with GMP requirements
Responsible for Quality review and approval of Raw Materials and Excipients for release to ensure compliance with GMP requirements
Responsible for completion of tasks and projects related to the management of Quality Assurance including change control, nonconformance investigation, incoming material release, batch release
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
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
Specific Experience as the person responsible for Batch Release (QA Specialist, Release)
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
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
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase