QC Incoming Supervisor

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for QC Incoming Supervisor located in Gurabo, PR.

The QC Incoming Supervisor is responsible for overseeing the incoming operations at the Gurabo site and approving the external warehouse incoming area.

Conducts thorough investigations related to raw materials and packaging components associated with the supplier manufacturing process events. Additionally, investigates questionable incoming inspection results and implement corrective actions. Compliance with quality control policies, procedures, and systems is essential to ensure the timely release of high-quality products.

Leads, facilitates, and provides guidance in the incoming operation and the external warehouse, ensuring overall compliance. Failure to perform these functions effectively could result in product recalls, production delays, and backorder status.

Key responsibilities:

• Ensure that all incoming area activities are performed in accordance with internal and external regulations, policies, and supply chain cycle time goals. Adhere to cGMP practices and compliance policies.

• Coordinate incoming activities to meet the needs of the supply chain.

• Follow the Raw Material priority report and in-process boards to support manufacturing rhythm wheels and adhere to business rules.

• Coordinate the timely review and approval of documentation generated by incoming inspectors, ensuring compliance with specifications.

• Provide technical support in the operation of laboratory equipment such as Infrared spectrophotometer, analytical balances, Raman, TVS, scanners, and computerized systems.

• Maintain accurate and organized records of all work performed

• Provide support for special projects, launches, validations, and method transfers.

• Participate in regulatory agency audits.

• Review and approve all standard operating procedures (SOPs), test methods, and verify their compliance with internal and external requirements. Issue, review, and approve Change Requests.

• Issue and review all deviations/investigations related to incoming inspection.

• Maintain and manage the retain room, including storage, discard, and annual evaluation.

• Responsible for supervising incoming coordinators and inspectors. 

• Ensure that all incoming activities are conducted on time in accordance with international regulatory requirements for the pharmaceutical industry. 

• Provide training to incoming personnel. 

• Coordinate and prepare the schedule for incoming materials sampling activities. 

• Evaluate the performance of incoming personnel. 

• Responsible for the collection and maintenance of retained samples. 

• Provide support during regulatory inspections, both internal and external. 

• Create and update area procedures.

• Retain complaint samples evaluation.

Qualifications

Required:

• Bachelor’s degree in engineering or science. 

• A minimum of six (6) years of related work experience in the pharmaceutical industry. 

• Familiarity with cGMP, as well as compliance and regulatory environments.

•  Knowledge/Training in Pharmacopoeias, Regulatory and Compliance.

• Strong knowledge of safety regulations. 

• Proficient at basic computer skills, data entry, as well as computer and software skills. 

• Strong technical writing skills.  

• Leadership skills.

Preferred:

• Strong analytical skills. 

• Attention to details. 

• Good organizational skills. 

• Good interpersonal and communication skills. 

• Overcome barriers to communication. 

• Handle multiple tasks. 

• Problem-solving, decision-making and troubleshooting skills. 

• High level judgment and discernment skills. 

• Facilitate and influence change. 

• Demonstrate business and technical acumen. 

Other:

• Fluent in both English and Spanish is required.

• Availability to work extended hours as required. 

• This position may require up to a 10% of domestic and/or international travel.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills: