DescriptionMcNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Senior Documentation Specialist located in Fort Washington, PA. 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, ROLAIDS?? antacid products, and SUDAFED??
nasal decongestants. Under minimal direction, The Senior Documentation Specialist performs all responsibilities necessary to provide oversight to Quality Systems Documentation which includes, translating regulatory standards and business processes into documented quality systems. This individual ensures timely document updates and revisions; provides direction and make decisions within the scope of the role and responsibility for a variety of tasks including but not limited to quality and compliance. This individual provides leadership to ensure adherence to all safety, environmental and quality policies and procedures; partners with the cross-functional teams to execute the necessary training and implementation of applicable documentation.
More specifically, the Senior Documentation Specialist creates procedural manuals and quality control manuals; ensures that each process has work instructions in place so that correct and consistent decisions are made during production; generates and examines documentation regularly for inconsistencies, gaps or errors; collaborates with relevant personnel to ensure accuracy of any revisions. This person writes or modifies test procedures and converts to process maps; ensures that any gaps are addressed and resolved; reviews proposals, contracts, regulatory, program and customer requirements for use in development of appropriate documentation in support of quality systems. The incumbent ensures provision of requested documents to support lawsuits and audits; processes incoming documents, such as validation and verification protocols and reports; implements document control systems and quality records procedures. This individual is also responsible for the adherence and performance of document management to applicable regulatory standards, company standards, SOPs.
The Senior Documentation Specialist will act as a mentor and coach in the Documentation functional area; assist management through change and transformation activities and will support strategic and tactical plans in alignment with the site's mission and plans. This individual will foster a climate of open communication, engagement and ownership within the team and build cross-functional working relationships. 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.QualificationsA minimum of a Bachelor's degree is required. A focused degree in Engineering, Science or Business is preferred. A minimum of 4 years of experience in a pharmaceutical, OTC, or other cGMP regulated environment is required. Prior experience in documentation management is necessary.
A demonstrated ability in documentation management systems is required. Experience with a Documentum based system is preferred. The ability to read/interpret/understand written policies, procedures, and instructions is required. Thorough understanding and knowledge of FDA, EMA and cGMP regulations is required.
Computer knowledge in Microsoft Office applications is required. The ability to effectively communicate and present information and instruction to peers and/or management representatives within a group or individual setting is required. Strong problem solving skills and the ability to make decisions and understand their impact on cGMPs and regulatory compliance are necessary. Ability to be self-directed and/or work in a team-based environment with minimal supervision is required.
The selected candidate must demonstrate ability to interact, motivate and implement required documentation in a manufacturing environment. This individual must also demonstrate analytical skills, process and data driven orientation, the ability to effectively resolve issues. This position is located in Fort Washington, PA and may require up to 10% travel. BE VITAL in your career, Be seen for the talent you bring to your work.
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- 3 years ago - save job