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PRODUCT RELEASE SPECIALIST III - 2nd Shift (1 of 2)-6875131218
Description
McNeil Consumer Healthcare Division of McNeil-PPC, Inc. is currently recruiting a Release Specialist III, to be located in Lancaster, PA.
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 III - 2nd Shift will ensures Quality System compliance as established in 21 Code of Federal Regulations (CFR) 210 and 211 Current Good Manufacturing Practices (CGMP) regarding quality methods and manufacturing and packaging processes and procedures. Conducts batch record review of completed batch record and performs final disposition of finished goods, packaging, and bulk transfer compiled records. Provides daily compliance leadership and support to Process Review Team (PRT). Supports Quality Unit by providing training/mentoring, participating in Non-Conformance (NC) investigations, and owning appropriate Action Items (AIs).
The Release Specialist III will perform under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines. General Compliance Functions: Ensures quality and compliance by adhering to procedures and remaining current in all required CGMP training. Promptly identifies, reports, and seeks corrections for workplace deviations. Embraces culture of employee involvement and commitment to doing the job right the first time. Completes all assigned, required training before associated task execution. Supports Consent Decree Work Plan activities. Supports other Quality Unit areas as necessary. Provides support during validation activities and special projects. Generates and evaluates change controls. Participates in change control and process improvement meetings.
The Release Specialist III will review completed batch records for accuracy and completeness, assuring conformance to established standards. Dispositions external bulk and finished goods including Release to Trade. Delivers CGMP training. Supports efforts for tactical compliance improvements. Trains new Release Specialists. Supports NC investigation completions. Takes ownership of appropriate Action Items.
The Release Specialist III will process Review Team Functions. Actively participates in PRT meetings. Strives to achieve daily quality outcomes for entire process from materials receipt through finished product shipment to the distribution centers. Provides real-time compliance consulting to PRT. Promotes PRT focus on QA compliance goals. Partners with team to investigate and resolve process, technical, and quality related issues. Partners with Process Management to support process improvement and provide ongoing support to meet metric goals. Identifies compliance gaps and provides proposed resolutions. Provides peer performance feedback.
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 (Science or technical degree) is required. A minimum of 5 years of Quality Unit experience in a GMP regulated environment is required. Demonstrated effective decision-making ability including the ability to ask proper questions and gather relevant information to form appropriate decisions is required. Demonstrated ability to maintain positive working relationships with others is required. Demonstrated leadership is required. Mathematics skills and analytical abilities are required. Ability to interpret and apply CGMP is required. Well-versed in latest Quality Assurance techniques is required. Previous batch record review experience is required. Basic computer knowledge of Microsoft Office (Excel, Outlook, and Word) is required. Must be able to make decisions based on available facts while meeting established deadlines and priorities is required. SAP (Systems, Applications and Products in Data Processing) and EDM (Electronic Document Management System) experience is required. Effective communication and organizational skills and keen attention to detail are preferred. Expertise in handling multiple priorities is preferred.
This role will be is a 2nd shift position and is based in Lancaster, PA and requires up to 10% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job: 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 III - 2nd Shift (1 of 2)-6875131218
Description
McNeil Consumer Healthcare Division of McNeil-PPC, Inc. is currently recruiting a Release Specialist III, to be located in Lancaster, PA.
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 III - 2nd Shift will ensures Quality System compliance as established in 21 Code of Federal Regulations (CFR) 210 and 211 Current Good Manufacturing Practices (CGMP) regarding quality methods and manufacturing and packaging processes and procedures. Conducts batch record review of completed batch record and performs final disposition of finished goods, packaging, and bulk transfer compiled records. Provides daily compliance leadership and support to Process Review Team (PRT). Supports Quality Unit by providing training/mentoring, participating in Non-Conformance (NC) investigations, and owning appropriate Action Items (AIs).
The Release Specialist III will perform under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines. General Compliance Functions: Ensures quality and compliance by adhering to procedures and remaining current in all required CGMP training. Promptly identifies, reports, and seeks corrections for workplace deviations. Embraces culture of employee involvement and commitment to doing the job right the first time. Completes all assigned, required training before associated task execution. Supports Consent Decree Work Plan activities. Supports other Quality Unit areas as necessary. Provides support during validation activities and special projects. Generates and evaluates change controls. Participates in change control and process improvement meetings.
The Release Specialist III will review completed batch records for accuracy and completeness, assuring conformance to established standards. Dispositions external bulk and finished goods including Release to Trade. Delivers CGMP training. Supports efforts for tactical compliance improvements. Trains new Release Specialists. Supports NC investigation completions. Takes ownership of appropriate Action Items.
The Release Specialist III will process Review Team Functions. Actively participates in PRT meetings. Strives to achieve daily quality outcomes for entire process from materials receipt through finished product shipment to the distribution centers. Provides real-time compliance consulting to PRT. Promotes PRT focus on QA compliance goals. Partners with team to investigate and resolve process, technical, and quality related issues. Partners with Process Management to support process improvement and provide ongoing support to meet metric goals. Identifies compliance gaps and provides proposed resolutions. Provides peer performance feedback.
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 (Science or technical degree) is required. A minimum of 5 years of Quality Unit experience in a GMP regulated environment is required. Demonstrated effective decision-making ability including the ability to ask proper questions and gather relevant information to form appropriate decisions is required. Demonstrated ability to maintain positive working relationships with others is required. Demonstrated leadership is required. Mathematics skills and analytical abilities are required. Ability to interpret and apply CGMP is required. Well-versed in latest Quality Assurance techniques is required. Previous batch record review experience is required. Basic computer knowledge of Microsoft Office (Excel, Outlook, and Word) is required. Must be able to make decisions based on available facts while meeting established deadlines and priorities is required. SAP (Systems, Applications and Products in Data Processing) and EDM (Electronic Document Management System) experience is required. Effective communication and organizational skills and keen attention to detail are preferred. Expertise in handling multiple priorities is preferred.
This role will be is a 2nd shift position and is based in Lancaster, PA and requires up to 10% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job: 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.