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Johnson & Johnson Innovative Medicine · 1 day ago

QA Specialist, C&Q/CSV

Wilson, NC

Full-time

Onsite

Entry, Mid Level

$79K/yr - $128K/yr

2+ years exp

Johnson & Johnson Innovative Medicine is dedicated to healthcare innovation, aiming to prevent, treat, and cure complex diseases. The QA Specialist will ensure compliance with regulatory requirements and company policies while overseeing quality assurance processes, including validation and qualification activities.

Pharmaceuticals

Responsibilities

Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans

Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project

Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP’s, Work Instructions and any other technical document

Review and approves validation protocols and reports (analytical, cleaning, process, etc.)

Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements

Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables

Perform QA reviews of system impact assessments and categorization of equipment and utilities

Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies

Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities

Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities

Reviews/approves Technology Transfer documents assuring they meet regulatory and J&J requirements

Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues

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

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 as required

Qualification

CGMP complianceQualification/validation lifecycleTechnical writingRisk-based approachesBiotherapeutic industry experienceCross-functional collaborationContinuous improvementProblem solvingDetail-orientedCommunication skills

Required

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

Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators – as well as Process Equipment – Bioreactors, UF/DF, centrifuge, Chromatography systems

Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation

Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles

Strong understanding of risk-based approaches to commissioning and qualification/validation

Proficiency in technical writing for validation and quality documents

Strong communication and interpersonal skills for cross-functional collaboration

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 Behavior

Coaching

Compliance Management

Continuous Improvement

Data Analysis

Detail-Oriented

Goal Attainment

Human-Centered Design

Internal Controls

Issue Escalation

Problem Solving

Process Oriented

Quality Control (QC)

Quality Management Systems (QMS)

Quality Standards

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