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J&J Family of Companies
Product Release Supervisor - 3rd Shift
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Production Release Supervisor - 3rd shift, located in Lancaster, 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.
Production Release Supervisor - 3rd shift 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. Manages Lancaster (LN) facility product batch record review and product disposition functions. Manages Consent Decree batch record review performed by third party CGMP expert, facilitating review process and ensuring sampling plan and CGMP expert review requirements are met. Provides compliance perspective and expertise to Shop Floor to ensure that the process consistently meets all internal and Regulatory Quality Standards. Supports site change control. Participates on cross-functional teams by providing compliance support. Ensures stability protocol and report verification and approval. Provides training and direction as needed to direct reports and guidance on setting objectives, frequent feedback and timely performance reviews to direct reports.
Product Release Supervisor functions: supervises release specialist activities, ensuring compliant, complete batch record review and approval. Provides compliance direction regarding product disposition decisions. Ensures any potential compliance issues identified during batch record review are corrected, clarified, and investigated in a compliant manner. Interfaces with planning group to prioritize critical lot disposition. Delivers QA Product Release presentations and metrics to LN staff and Quality Management. Authors and revises area controlled documentation, including Standard Operating Procedures (SOPs) and Work Instructions (WI), to ensure CGMP compliance. Serves as a Product Release Subject Matter Expert during regulatory audits/inspections. Manages third party CGMP expert batch record review per Consent Decree. Assures continuous process improvement of product disposition processes.
Product Release Supervisor QA Shop Floor 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. Participates in PRT efforts to investigate and resolve day to day compliance, process, technical and quality issues. Ensures quality and compliance by ensuring direct reports and subordinates remain current with training requirements and train on required procedures before associated task execution. Promotes an environment of employee workplace involvement. Seeks prompt identification, reporting, and correction of workplace deviations. Acts as signatory on compliance documentation - including (but not limited to) Quality Notifications (Investigations), Change Controls, Standard Operating Procedures, Master Batch Records, Packaging Line Trials, Equipment IQ/OQ/PQ Protocols and Reports, and Annual Product Reviews. Participates on cross-functional teams by providing compliance guidance. Strives to continuously improve the process by optimizing reporting and information presentation. Provides support to LN Quality Assurance. Supports Consent Decree Work Plan activities.
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.
A minimum of Bachelor's degree in a scientific/technical discipline such as chemistry, biology, microbiology, virology, engineering or pharmacy is required. A minimum of 5 years of GMP regulatory industry experience in Quality Assurance and/or Product Release related work experience in a pharmaceutical and/or biological manufacturing operation required. Experience in a Pharmaceutical OTC (Over-the-counter) drug production environment preferred. GMP manufacturing process/laboratory experience preferred. Technical writing and experience writing and assembling Annual Product Review summaries preferred. LIMS (Laboratory Information Management System), EtQ (Excellence through Quality), SAP (Systems, Applications and Products in Data Processing) and EDM (Electronic Documentation Management System) experience is preferred. Mathematics skills and analytical abilities required. Ability to interpret and apply CGMP required. Knowledge and skills in validation processes and statistical process control, detection, correction and error prevention, process system challenges, sampling, audits, root cause analysis, and risk management is preferred. Basic computer knowledge is required such as Microsoft Office (Excel, Outlook, PowerPoint, and Word). Must be able to make decisions based on available facts while meeting established deadlines and priorities required. Previous experience leading a team is preferred. Demonstrated effective communication skills is required. Solid organizational skills and keen attention to detail is required. Ability to author SOPs, non-conformance and/or Corrective and Preventive Action (CAPA) investigation skills preferred. Expertise in handling multiple priorities is required.Registered Qualified Person (QP) or capable of attaining QP certification preferred, certified Quality Engineer or ASQ certification preferred. Ability to work on cross-functional teams required
This candidate will be based in Lancaster, PA and will be required to travel less than 10% domestically. This position is a 3rd shift.
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-US-Pennsylvania-Lancaster
Organization: McNeil-PPC, Inc. (6101)
Job Function: Quality Assurance
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.
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Req ID
Date: Tue, 10 06 2014 00:00:00 GMT
Country: US
State: PA
City: Lancaster
Postal Code: 17573
Locale: en_US - Free Classified Ads in US on Craigslist