Johnson & Johnson companies are equal opportunity employers.
External Manufacturing Operations Change Control Technical Writer (1 of 2)-5948140313
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an External Manufacturing Operations Change Control Technical Writer, located in Fort Washington, Pennsylvania.
McNeil Consumer Healthcare Division of McNeil-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
The CC Tech Writer will ensure compliance by coordinating Change Controls associated with McNeil and External Manufacturing (EM) site initiated changes. The CC Tech Writer will initiate EtQ system CC requests to be communicated to External Manufacturing, Testing, and Packaging sites with input from the EM Site Leader, Quality Account Manager (QAM) and other Subject Matter Experts (SMEs) as needed. The CC Tech Writer will present CC Requests at Change Control Committee (CCC) Meetings and interface with the CC approvers to align CC wording, requirements and deliverables as needed to facilitate approval process.
As part of this role, the CC Tech Writer will track/monitor CCs through their lifecycle. This includes, but is not limited to timely promotion & notification of change in status, regular updates to CC owners (Site Leaders, QAMs & SMEs) on CCs and deliverable status, weekly monitoring and reporting of change control metrics including submissions, approvals and closures. This role will coordinate deliverables execution and documentation in CC as deliverables are received and ensure CCs are closed in a timely manner or initiate extensions when necessary if Target Closure Date is not attainable.
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 Bachelor's Degree is required. A focus degree in Science or Engineering Technologies is preferred. A minimum of 4 years’ experience in a GMP regulated environment (pharmaceutical etc.) is required. A technical writing background is preferred. Experience with pharmaceutical or consumer manufacturing (processing/packaging, etc.) is required. Experience with facilities, validation, analytical sciences, microbiology or engineering is preferred.
The ability to handle multiple, at times complex change controls at one time is required. The ability to read, analyze and interpret common scientific and technical documents is required. Organizational skills and the ability to adapt to a fast-paced environment with changing priorities is preferred. The ability to effectively present information and communicate clearly to all levels of management is required. The ability to work directly with external manufacturing sites under limited supervision is preferred. Knowledge of computer systems and proficiency with Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, PowerPoint, and Access skills are preferred). Previous experience working in cross functional matrix environment with an ability to influence without authority is required. Knowledge of six sigma, process improvement or lean is preferred. Individual must demonstrate the following: detail and goal oriented, work in a team environment, customer-focus, ability to manage multiple projects, prioritize and adapt to business needs, have a thorough understanding of compliance requirements, effective verbal and written communication skills, interdependent partnering, strong decision-making/analysis skills, problem-solving and Lean mindset.
This candidate will be based in Fort Washington, PA and will be required to travel less than 10% domestically.
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Control
Travel:Yes, 10 % of the Time
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
External Manufacturing Operations Change Control Technical Writer (1 of 2)-5948140313
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an External Manufacturing Operations Change Control Technical Writer, located in Fort Washington, Pennsylvania.
McNeil Consumer Healthcare Division of McNeil-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB and SUDAFED® nasal decongestants.
The CC Tech Writer will ensure compliance by coordinating Change Controls associated with McNeil and External Manufacturing (EM) site initiated changes. The CC Tech Writer will initiate EtQ system CC requests to be communicated to External Manufacturing, Testing, and Packaging sites with input from the EM Site Leader, Quality Account Manager (QAM) and other Subject Matter Experts (SMEs) as needed. The CC Tech Writer will present CC Requests at Change Control Committee (CCC) Meetings and interface with the CC approvers to align CC wording, requirements and deliverables as needed to facilitate approval process.
As part of this role, the CC Tech Writer will track/monitor CCs through their lifecycle. This includes, but is not limited to timely promotion & notification of change in status, regular updates to CC owners (Site Leaders, QAMs & SMEs) on CCs and deliverable status, weekly monitoring and reporting of change control metrics including submissions, approvals and closures. This role will coordinate deliverables execution and documentation in CC as deliverables are received and ensure CCs are closed in a timely manner or initiate extensions when necessary if Target Closure Date is not attainable.
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 Bachelor's Degree is required. A focus degree in Science or Engineering Technologies is preferred. A minimum of 4 years’ experience in a GMP regulated environment (pharmaceutical etc.) is required. A technical writing background is preferred. Experience with pharmaceutical or consumer manufacturing (processing/packaging, etc.) is required. Experience with facilities, validation, analytical sciences, microbiology or engineering is preferred.
The ability to handle multiple, at times complex change controls at one time is required. The ability to read, analyze and interpret common scientific and technical documents is required. Organizational skills and the ability to adapt to a fast-paced environment with changing priorities is preferred. The ability to effectively present information and communicate clearly to all levels of management is required. The ability to work directly with external manufacturing sites under limited supervision is preferred. Knowledge of computer systems and proficiency with Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, PowerPoint, and Access skills are preferred). Previous experience working in cross functional matrix environment with an ability to influence without authority is required. Knowledge of six sigma, process improvement or lean is preferred. Individual must demonstrate the following: detail and goal oriented, work in a team environment, customer-focus, ability to manage multiple projects, prioritize and adapt to business needs, have a thorough understanding of compliance requirements, effective verbal and written communication skills, interdependent partnering, strong decision-making/analysis skills, problem-solving and Lean mindset.
This candidate will be based in Fort Washington, PA and will be required to travel less than 10% domestically.
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Control
Travel:Yes, 10 % of the Time
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement