Vacancy caducado!
QA Process Control Lead Expanding pharmaceutical company is adding a QA Process Control Lead to their team. Join our growing organization and expand your skills while helping patients in need.
Position Summary This position requires a hands-on high-level expertise in quality assurance for the pharmaceutical manufacturing processes. The QA Process Control Lead will be responsible for supervising routine work, providing direction, and training to Quality Control Team members. Responsible for performing in-process inspection and process monitoring, batch record review and release activities, label control and quality investigations/resolution, process verifications to ensure compliance with operating procedures and specifications. Essential Duties -Recommend and/or implement improvements in streamlining processes and procedures in the areas of manufacturing, validation, change control, laboratory, and risk assessments. -Lead root-cause analysis and corrective and preventive actions for audit observations, product complaints, product non-conformances, in-process deviations, CAPA, and SCAN issues related to process controls. -Direct the investigation of excursions in Manufacturing or other related operations. Resolves nature of the cause, impact on product quality, disposition and corrective actions. -Supervise routine work, provide direction, and training to team members. -Ensures the efficient use of resources in order to achieve department quality and operation plan objectives. -Performs final review of test data/reports to ensure conformance to the established specifications and standard operating procedures. -Writes collects, organizes and compiles data and reports to provide information for use by management or to comply with goals and regulatory requirements. -Prepare/revise operating procedures and specifications. -Review/approve routine change control requests as designated. -Perform manufacturing process verifications to ensure compliance with operating procedures and specifications (for example, verify proper line clearance, compliance with operating and inspection procedures, operation of equipment per validated parameters, equipment calibrated, operators trained, compliance with gowning and clean room procedures, etc.) -Responsible for responding to clean room alarms to verify compliance with excursion requirements. Assess status and determine the appropriate actions needed to be taken. Control of product labeling/Label accountability. -Review of batch records including control check sheets, notebooks, raw data, reports, certificates of analysis, etc. to ensure completeness, accuracy and conformance with specifications. -Provide support for quality investigations and resolution of quality issues. -Compile, report and interpret quality trend information. -Perform all activities with a working knowledge of Company procedures and specifications and government regulations that govern the process. -Review data and assign disposition to test results including but not limited to environmental data, in-process audit results. -Maintain current knowledge of regulatory and industry standards, trends and advancement. -Conduct routine and non-routine audit and analysis of in-process activities according to established procedures. -Maintain accurate, complete records and ensure documentation is consistent with written procedures. -Prepare and revise procedures to comply with cGMP requirements based on current processes and observation results from in process audits. -Work independently and effectively with various quality functions to assure conformance to FDA regulatory requirements and internal processes and policies. -Work effectively across different business units. -Uses computerized systems needed for product release and control, document control and quality investigation processes. -Prioritize tasks in a high pressure and deadline driven environment. -Oversee process controls to ensure product quality and all specifications are met. Ensure products are released on time and within specification. Knowledge & Skills -Good working knowledge of Pharmaceutical (USP, 21 CFR 210 & 211, and 503B) -Good working knowledge of USP, FDA/cGMP, ISO, and ICH requirements -Effective communication skills, both written and verbal. -Leadership skills and the ability to facilitate the work activities of others -Ability to act effectively as a member of a team to resolve problems. -Ability to analyze and troubleshoot -Advanced and specialized expertise, typically developed through a combination of job-related training and considerable on-the-job experience.Qualifications:-BS degree in technical or scientific discipline and five or more years of related experience preferably in the pharmaceutical and or medical device industry. -Ability to work autonomously within established procedures and practices. -Experience with USP, cGMP's, and FDA guidelines.Apply today for immediate consideration to EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at orVacancy caducado!