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QC Laboratory Supervisor - 2nd shift-2112130709
Description
Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Control Laboratory Supervisor - 2nd Shift, located in Gurabo, Puerto Rico.
Janssen Ortho LLC., provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologic (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit http://www.janssenpharmaceuticalsinc.com/
The QC Laboratory Supervisor leads, oversees and coordinates activities of QC Analysts in support of new product introductions. Reviews and approve a variety of documents, procedures, testing, methods as is responsible for coordinating, reviewing and approving all chemical and physical testing tied to the introduction of new products according with internal and compendia specifications. The incumbent will perform investigations when questionable analytical results have been generated and works in the corrective action implementation. Assures the compliance to all quality control policies, procedures and systems, to ensure the timely release of high quality product in support the supply chain process. The incumbent will assure that all laboratories analyses are performed in accordance with internal and external regulations and policies and consistent with supply chain cycle time goals. Coordinates laboratory activities according to the supply chain needs. Responsible for laboratory reporting in support of new product introductions and related operations / manufacturing processes. Reviews and approves documentation of data generated by Lab Scientist in a timely manner and according to specifications. Maintains accurate and neat records of all work performed. Support on special projects such as equipment calibration, validation and method transfers. Develops and reviews all laboratory SOP's and verifies its compliance with internal and external requirements. Works on the assessment of suspect results or process/method deviations to assure the data integrity and proper and complete documentation. Comply with J&J Safety Requirements and ensure safe working conditions and practices in the department. Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company. Complies with the goals of the quality team and with overall business and process goals. Assures all equipment used is calibrated and properly qualified and troubleshoots equipment accordingly. This individual must thrive in a cross-functional collaborative environment. In addition, must be able to train and coach team members as well as implement improvement plans as needed. Other duties may be assigned.
Qualifications
This position requires a Bachelor’s Degree in Chemistry, and an up to date PR Chemist License. A minimum of six (6) years of analytical laboratory experience in the regulated pharmaceutical industry with knowledge of cGMP’s is required. At least two (2) years of laboratory supervisory experience required. Overall experience in the Quality Control unit at the exempt level is required. Experience with project management, cleaning validation and method transfers is required. Experience in analytical techniques like HPLC, UPLC, GC, Dissolution, TOC, FTIR, UV-Visible and wet chemistry is highly preferred. Expertise in introducing new methods and processes. Be familiarized with US and International cGMPs and Pharmacopoeia. The candidate must have strong leadership, analytical and technical writing skills. Able to handle multiple tasks. The selected candidate must show good interpersonal skills, ability to manage complexity and conflict, strong problem solving, decision-making skills and the ability to influence others regarding quality goals. Excellent communication skills in English and Spanish are required. The incumbent should have high technical knowledge of Chemistry with a broad knowledge in analytical techniques. Advanced computer proficiency and software skills are required. Available to work on a 2nd shift is required. Physical requirements of the position include carrying less than 10 pounds occasionally, and requires sporadic pull and push, bend forward and backwards, twist waist and neck, hand arm; frequently stand, walk, sit, talk, listen, grab with one or both hands; and constantly close vision, handwriting, use of computer and general offices machines / tools, laboratory equipments and instruments.
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI
Primary Location:North America-United States-Puerto Rico-Gurabo
Organization: Janssen Ortho LLC (2162)
Job Function: Quality Control
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
QC Laboratory Supervisor - 2nd shift-2112130709
Description
Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Control Laboratory Supervisor - 2nd Shift, located in Gurabo, Puerto Rico.
Janssen Ortho LLC., provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologic (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit http://www.janssenpharmaceuticalsinc.com/
The QC Laboratory Supervisor leads, oversees and coordinates activities of QC Analysts in support of new product introductions. Reviews and approve a variety of documents, procedures, testing, methods as is responsible for coordinating, reviewing and approving all chemical and physical testing tied to the introduction of new products according with internal and compendia specifications. The incumbent will perform investigations when questionable analytical results have been generated and works in the corrective action implementation. Assures the compliance to all quality control policies, procedures and systems, to ensure the timely release of high quality product in support the supply chain process. The incumbent will assure that all laboratories analyses are performed in accordance with internal and external regulations and policies and consistent with supply chain cycle time goals. Coordinates laboratory activities according to the supply chain needs. Responsible for laboratory reporting in support of new product introductions and related operations / manufacturing processes. Reviews and approves documentation of data generated by Lab Scientist in a timely manner and according to specifications. Maintains accurate and neat records of all work performed. Support on special projects such as equipment calibration, validation and method transfers. Develops and reviews all laboratory SOP's and verifies its compliance with internal and external requirements. Works on the assessment of suspect results or process/method deviations to assure the data integrity and proper and complete documentation. Comply with J&J Safety Requirements and ensure safe working conditions and practices in the department. Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company. Complies with the goals of the quality team and with overall business and process goals. Assures all equipment used is calibrated and properly qualified and troubleshoots equipment accordingly. This individual must thrive in a cross-functional collaborative environment. In addition, must be able to train and coach team members as well as implement improvement plans as needed. Other duties may be assigned.
Qualifications
This position requires a Bachelor’s Degree in Chemistry, and an up to date PR Chemist License. A minimum of six (6) years of analytical laboratory experience in the regulated pharmaceutical industry with knowledge of cGMP’s is required. At least two (2) years of laboratory supervisory experience required. Overall experience in the Quality Control unit at the exempt level is required. Experience with project management, cleaning validation and method transfers is required. Experience in analytical techniques like HPLC, UPLC, GC, Dissolution, TOC, FTIR, UV-Visible and wet chemistry is highly preferred. Expertise in introducing new methods and processes. Be familiarized with US and International cGMPs and Pharmacopoeia. The candidate must have strong leadership, analytical and technical writing skills. Able to handle multiple tasks. The selected candidate must show good interpersonal skills, ability to manage complexity and conflict, strong problem solving, decision-making skills and the ability to influence others regarding quality goals. Excellent communication skills in English and Spanish are required. The incumbent should have high technical knowledge of Chemistry with a broad knowledge in analytical techniques. Advanced computer proficiency and software skills are required. Available to work on a 2nd shift is required. Physical requirements of the position include carrying less than 10 pounds occasionally, and requires sporadic pull and push, bend forward and backwards, twist waist and neck, hand arm; frequently stand, walk, sit, talk, listen, grab with one or both hands; and constantly close vision, handwriting, use of computer and general offices machines / tools, laboratory equipments and instruments.
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI
Primary Location:North America-United States-Puerto Rico-Gurabo
Organization: Janssen Ortho LLC (2162)
Job Function: Quality Control
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.