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PRODUCT RELEASE SPECIALIST I - 2nd Shift-8878140113
Description
McNeil Consumer Healthcare markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products; BENADRYL®, ZYRTEC® and ZYRTEC®-D allergy medicines; IMODIUM® A-D anti-diarrheal; MOTRIN® IB; and SUDAFED® and SUDAFED PE® nasal decongestants.
The Release Specialist I - 2nd Shift will be responsible for tactical activities related to product release for the Plant, assuming the responsibility and authority to recommend the approval or rejection of goods based on their conformance to established standards. He/she will provide daily support to the Process Review Team (PRT) consistent with the supply chains’ goals while meeting the compliance goals of Quality Assurance. Supports Quality group by participating in investigations (NCs) and may own Action Items (AIs).
The Release Specialist I will attend GMP training on the schedule designated for my role and as appropriate for my role. He/she will adhere to strict compliance with procedures applicable to the role. This individual will exercise the highest level of integrity in the tasks performed. The Release Specialist I, in a timely and prompt manner will identify, report and seek correction for deviations noted in my workplace. He/she will embrace a behavior of employee involvement and commitment to doing the job right the first time.
The Release Specialist I will be responsible for the final audit of records associated with product release – assuring their conformance to established standards. He/she will be responsible for disposition of external bulk and Finished Goods including Release to Trade within the SAP system. The Release Specialist I will be responsible for the audit of blocked material. (in-house warehouse and off-site warehouse). He/she will support efforts for tactical compliance improvements. The Release Specialist I will support the completion of Non Conformance Investigations as well as have ownership of Action Items as appropriate.
The Release Specialist I will actively participate at Process Review Team Meetings. He/she will team with process members to investigate and resolve day-to-day process, technical and quality problems. This individual will encourage Team focus on QA compliance goals. The Release Specialist I will team with process management to support process improvement and ongoing support in meeting metrics goals. He/she will be responsible for achieving day-to-day process outcomes for the entire process. This individual will identify Compliance gaps and provide resolution proposals. He/she will provide performance feedback on peers.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelor’s Degree and 1 year experience in a Pharmaceutical cGMP environment is required. Strong decision-making ability is required. Previous familiarity with SOP’s (reading and/or authoring) is preferred. SAP and EDM experience is required. Previous batch record review experience is required. Familiarity with operations within a Pharmaceutical GMP environment is preferred. Experience with granulation, compression and package records is preferred. Change control experience is preferred. Investigations experience is preferred. Keen attention to detail is required. Expertise in handling multiple priorities is required. Demonstrated ability to maintain positive working relationships with others is required. The ability to demonstrate firm conviction on regulatory boundaries, in the face of challenges and pressures while maintaining professionalism and diplomacy is required. The ability to demonstrate communication and organizational skills is required. Strong appreciation for quality in the process and the product is required.
This role is 2nd Shift and will be based in Lancaster, PA and requires up to 10% travel.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
Relocation: Eligible No
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.
PRODUCT RELEASE SPECIALIST I - 2nd Shift-8878140113
Description
McNeil Consumer Healthcare markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products; BENADRYL®, ZYRTEC® and ZYRTEC®-D allergy medicines; IMODIUM® A-D anti-diarrheal; MOTRIN® IB; and SUDAFED® and SUDAFED PE® nasal decongestants.
The Release Specialist I - 2nd Shift will be responsible for tactical activities related to product release for the Plant, assuming the responsibility and authority to recommend the approval or rejection of goods based on their conformance to established standards. He/she will provide daily support to the Process Review Team (PRT) consistent with the supply chains’ goals while meeting the compliance goals of Quality Assurance. Supports Quality group by participating in investigations (NCs) and may own Action Items (AIs).
The Release Specialist I will attend GMP training on the schedule designated for my role and as appropriate for my role. He/she will adhere to strict compliance with procedures applicable to the role. This individual will exercise the highest level of integrity in the tasks performed. The Release Specialist I, in a timely and prompt manner will identify, report and seek correction for deviations noted in my workplace. He/she will embrace a behavior of employee involvement and commitment to doing the job right the first time.
The Release Specialist I will be responsible for the final audit of records associated with product release – assuring their conformance to established standards. He/she will be responsible for disposition of external bulk and Finished Goods including Release to Trade within the SAP system. The Release Specialist I will be responsible for the audit of blocked material. (in-house warehouse and off-site warehouse). He/she will support efforts for tactical compliance improvements. The Release Specialist I will support the completion of Non Conformance Investigations as well as have ownership of Action Items as appropriate.
The Release Specialist I will actively participate at Process Review Team Meetings. He/she will team with process members to investigate and resolve day-to-day process, technical and quality problems. This individual will encourage Team focus on QA compliance goals. The Release Specialist I will team with process management to support process improvement and ongoing support in meeting metrics goals. He/she will be responsible for achieving day-to-day process outcomes for the entire process. This individual will identify Compliance gaps and provide resolution proposals. He/she will provide performance feedback on peers.
All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelor’s Degree and 1 year experience in a Pharmaceutical cGMP environment is required. Strong decision-making ability is required. Previous familiarity with SOP’s (reading and/or authoring) is preferred. SAP and EDM experience is required. Previous batch record review experience is required. Familiarity with operations within a Pharmaceutical GMP environment is preferred. Experience with granulation, compression and package records is preferred. Change control experience is preferred. Investigations experience is preferred. Keen attention to detail is required. Expertise in handling multiple priorities is required. Demonstrated ability to maintain positive working relationships with others is required. The ability to demonstrate firm conviction on regulatory boundaries, in the face of challenges and pressures while maintaining professionalism and diplomacy is required. The ability to demonstrate communication and organizational skills is required. Strong appreciation for quality in the process and the product is required.
This role is 2nd Shift and will be based in Lancaster, PA and requires up to 10% travel.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
Relocation: Eligible No
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.
