Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Annual Product Review Specialist III in Lancaster, PA
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
The Annual Product Review Specialist III will support the Product Support Quality Assurance (PSQA) group in the McNeil facility in Lancaster, PA. This individual is responsible for ensuring ongoing QA compliance functions are met relative to Annual Product Reviews (APR) with the primary function of compiling, organizing, analyzing and approving information from the data contributors for the APRs for products manufactured or packaged in the Lancaster (LN) plant. They will also conduct a holistic review for overall trends and author the executive summary and present to the APR Supervisor for review. This individual will assist in circulation of the completed APR for review and approval; facilitates completion of the management review requirement to meet expected APR completion dates; designs and may deliver APR presentations/metrics as needed to both site staff and Quality Management. As necessary, this individual updates site or related Standard Operating Procedures (SOPs) and Work Instructions (WI); maintains access in CAPA and Investigation system(s); supports site during regulatory inspections and may present as Subject Matter Expert.
The APR Specialist III may also be required to participate in cross functional teams providing compliance support as needed. This individual will strive to continuously improve the process by optimizing reporting and presentation of information. This individual will evolve the program to continuously meet current enforcement guidelines (cGMP); provide support to the Lancaster PSQA group and performs other related duties as required.
Annual Product Review Functions:
• Assures that the annual schedule is maintained and that APRs are completed as scheduled.
• Notifies individual contributors of expected document summaries and timelines; escalates issues.
• Performs a statistical analysis of information for the APR as needed.
• Reviews, analyzes and approves all information/summaries contained in the APR.
• Reviews and assures adequate documentation is included for observed trends.
• Reviews APR information in total; assures document is assembled correctly.
• Drafts the management summary statement for the APR.
• Assists in the circulation of the completed APR for review and approval.
• May facilitate completion of the management review requirement to meet expected APR completion dates.
• May deliver APR presentations/metrics as needed to both site staff and Quality Management.
• May update site or related Standard Operating Procedures (SOPs) and Work Instructions (WI).
• Maintains access in CAPA and NC system(s).
• Supports site during regulatory inspections; presents as Subject Matter Expert.
• May be required to participate in cross functional teams providing compliance support as needed.
• Strives to continuously improve the process by optimizing reporting and presentation of information.
• Evolves program to continuously meet current enforcement guidelines (cGMP).
• Provides support to the Lancaster Quality Systems group (APR, Document Control and Training).Qualifications
• A B.Sc. or B.A. in a technical discipline such as Chemistry, Biology, Microbiology, Pharmacy, or other related field is required.
• A minimum of 4 years’ experience in a GMP related industry with a focus on Quality Assurance is required.
• Experience in a Pharmaceutical/OTC drug production environment is required.
• The ability to analyze data using statistical tools is required.
• Technical writing experience is required.
• Experience writing and putting together Annual Product Review summaries is highly preferred.
• Understanding of New Drug Development process, Technical Transfer and Process Validation is preferred.
• Knowledge of cGMP requirements is required.
• Six Sigma, Lean or ASQ CQE Certification and training are preferred.
• Able to work independently with minimum supervision required.
• Strong appreciation for quality in the process and the product required.
• Ability to work on cross functional teams required.
• Requires a professional and ethical approach to all activities and dealings.
• Keen attention to detail required.
• Demonstrated ability to maintain positive working relationships with others.
• Expertise in handling multiple priorities preferred.
• This position may require up to 10% domestic travel and will be based in Lancaster, PA.
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J2W: LI NAPrimary Location
J & J Consumer Inc. (6101)Job Function
Quality AssuranceRequisition ID