QC Specialist - General
QC Specialist - General
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Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
QualityJob Sub Function:
Quality ControlJob Category:
ProfessionalAll Job Posting Locations:
Wilson North Carolina United States of AmericaJob Description:
Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology immunology and neuroscience. J&Js significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
Essential Job Duties and Responsibilities:
- Responsible for execution of biochemical microbiological and/or general chemical testing within the QC Microbiology laboratory.
- Develops and executes analytical method qualification validation and transfer with minimal guidance.
- Performs peer review and/or approval of laboratory data.
- Authors reviews or approves related SOPs WIs and technical documents.
- Trains and mentors incoming QC Microbiology laboratory personnel.
- Utilizes electronic systems (eLIMS MES etc.) for execution and documentation of testing.
- Maintains a safe work environment in compliance with all applicable environmental health and safety regulations
- Collaborates with cross-functional teams (Operations Engineering & Maintenance MSAT QA
- etc) to address quality issues
- Performs statistical analysis data trending and reporting.
- Proficient with using Microsoft Office applications (Outlook Excel Word and Powerpoint)
- Provides input to functional laboratory meetings.
- Provides QC input at cross-functional meetings.
- Supports Health Authority inspections.
- Maintains individual training completion in a compliant state.
Qualifications:
- Bachelors degree in Chemistry Microbiology Biology Biochemistry or related field is required.
- Minimum six (6) years experience working within the biological and/or pharmaceutical industry in a laboratory setting is required.
- Prior demonstrated success at the QC analyst level and/or an equivalent combination of education and experience is required.
- Strong knowledge of compendial (USP EP JP etc.) requirements and standards for QC testing.
- Strong working 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.
Other Requirements:
- 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 and communicate complex quality concepts to stakeholders at all levels.
- 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.
- The ability to work in a team environment and interact with all levels of the organization.
Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time or to vary the duties and responsibilities of the position to meet production scheduling or other business needs.
If you are passionate about quality in the pharmaceutical industry and possess the necessary skills and experience we invite you to apply for this exciting opportunity as a QC Specialist. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Required Experience:
Unclear Seniority
Employment Type
Full-Time
