Vacancy caducado!
Please note that this is a 1 year contract position. - Position will sit onsite 100% of the time- Schedule is flexible, but could be M-F 730am-400pm- Train for 2-3 weeks- There will be probably 2 interviews before candidate is selected- Travel - should not be any unless a project comes up at another site and they need help (not very likely but need to be open to possible travel just in case. Would not be on a regular basis)- Associates Degree or higher required, Science background highly preferred- At least 2 years of experience- Must be well organized and very detailed- Will be reviewing Batch Records and reviewing complaints- Will be creating certificates for foreign affiliates- Will interact with manufacturing shop floor and/or plant workers- Must have GMP experience/knowledge- Must have excellent communication skills- Will also help file paperworkPOLICIES: Know & follow policies & procedures related to work activities performed in area of responsibility.TRAINING: Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training in areas such as safety & environmental compliance.SAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work area. Follow Health Care Compliance guidelines as well as follow operating room training and safety standards.
Position OverviewSupport batch record release team by reviewing/compiling batch record documentation, generating certificates for foreign affiliates and completing batch record review for complaints. All tasks will be completed with the good manufacturing and documentation practices as established in the code of local government regulations and company procedures.Key Responsibilities Perform quality review of production records including manufacturing, packaging, and laboratory documents. Responsible for quality releases of finished product based on conformance to established standards Review compliance records, specifications, procedures and other documents, as required. Assists in document preparation for regulatory agency visits and Corporate/internal audits. Prepare and send certificates of analysis for foreign affiliates. Review batch records for complaint investigations. Conduct walkthroughs and assessments of GMP areas. Partner with Operations for issue resolution. File completed batch records appropriately. Apply quality assurance processes, procedures, and activities. Documentation is clear and grammatically correct in accordance with GMP and site procedures. Under direction from management, participate in continuous improvement projects. Report improvements to management. Other tasks as determined by management. Ensure quality and compliance in all my actions by:All employeesa. Attend GMP training on the schedule designated for my role and as appropriate for my role.b. Adhere to strict compliance with procedures applicable to my role.c. Exercise the highest level of integrity in the tasks that I perform.d. In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.e. Embrace a behavior of employee involvement and commitment to doing the job right the first time.ESSENTIAL FUNCTIONS: Define key accountabilities and/or activities. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. % OF TIMESupport batch record release team by reviewing/compiling supporting documentation and preparation of foreign affiliates certificates of analysis. 50%Conduct area walkthroughs and assessments as well as provide real-time support to Product Manufacturing and Packaging. 30%Review batch records for complaint investigations. 20%QualificationsEducation:• Associates Degree or higher required, Science background highly preferredExperience:• A minimum of 2 years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production.Knowledge, Skills and Abilities:• Basic working knowledge of cGMP requirements and current FDA enforcement issues.• Ability to communicate thoughts and ideas effectively – verbal and written.• Demonstrated ability to accomplish work goals.• Effectively work within a team environment.Applicants must provide their phone number. Reference job number A2027.Vacancy caducado!