Packaging Supervisor - Charlotte
Qualitest Pharmaceuticals - Charlotte, NC

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Lead direct reports within the Value Stream Organization to ensure its capability to deliver quality product, on time, safely and effectively to meet our customers’ needs. Work with planning, Value Stream Leadership Team to develop a culture of accountability, empowerment, continuous improvement, customer focus, collaboration celebration of good work and involvement and development of all people within the Value Stream.Maintain high standards in terms of Safety and cGMP’s, and manufacturing efficiency.Responsibilities: Compliance, Safety and Quality (30%)Ensure that, during all manufacturing operations, the site’s safety and quality and compliance metrics are met or surpassed while meeting corporate and site standards and policies.Ensure quality and safety requirements are clearly defined, robust processes are in place and capable employees are properly trained to guarantee compliance with all current state, federal and local standards and regulations, e.g., cGMP, GLP, OSHA, EEOC, EPA, and DEA.Alert management of any potential deviations or infractions in a timely manner.Mutual accountability with VSO Leadership team to investigate, propose and initiate corrective and preventative action (CAPA) for equipment and process related issues based on root cause analysisMutual Accountability to review, and propose revisions to Manufacturing batch records and SOP's as requiredEnsure that all employees training curricula's are up to date.Assure all batch records are reviewed, corrected and submitted to IPQA.Provides guidance and directions to team membersRecommends future directions within area of expertiseServes as prime contact for department trainingIdentifies potential process improvementsWorks toward long-range goals and objectives Review in process data logs, assure that observations are addressed and sign off on reviewed pages in real time. Initiate/review/approve Variance/Observation forms and deviation. Assist with investigations and ensureCreate standard work processes and partner with Training Unit Leader to ensure compliance with the training of applicable site personnel.Business (30%)Effectively communicate and flow down objectives to all employees.Support the creation and maintenance of a “Visual Factory” to provide daily feedback on performance to objectives.

Support and maintain a closed loop management process that drives continuous improvement in performance to objectives and fact based decision making.Support the development of schedules, release of batch records, inventory levels / controls, assignment of work, running of manufacturing processes, accurate completion of all records and approvals to deliver quality product on time with exceptional customer service.Hold employees accountable for execution of assigned duties, managing defined roles & responsibilities, meeting objectives.Drive continuous improvement and execute pro-active quality control in Value Stream processes Point out possible difficulties in, and assure compliance with the company scheduleAccurately complete expense reports before the monthly due date.Employee Development (25%)Participate in the recruitment, selection, promotion, and retention of Value Stream personnel.Recognize and Reward employees that consistently perform at high levels or go above and beyond their required job duties in order to maintain a high level of employee moraleAssure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance. Consistently communicate, follow and enforce SOP’s and company policies and guidelines set forth in the employee handbook.Identify the developmental needs of others and provide coaching, mentoring, and encouragement to help others to improve their knowledge or skills.Provide regular coaching and performance feedback to employees in addition to conducting annual performance reviews. Recognize and implement performance improvement plans when needed in consultation with Human Resources Business Partner.Review attendance records, PTO time and approve/deny employee time-off requests and take disciplinary action as required.Organization Support (15%)Oversee the staffing plan based on available resources and give assignments to Operators.Work with all Value Stream counterparts to develop a culture of accountability, empowerment, and continuous improvement, customer focus, collaboration with celebration of good work and involvement, and development of all people within the Value Stream.Monitor and review reconciliation of batch record and other related documents.Assist with Value Stream related projects as directed by Manager.Attend Manufacturing related meetings on timeRequirements: Skills: (Proficiency in manual, verbal or mental manipulation of data or things e.g. specific software skill, data manipulation skills such as modeling)Strong leaderships, team building, and communication skillsStrong focus on quality and proven ability to apply a high degree of integrity.Identify the developmental needs of others and provide coaching, mentoring, and encouragement to help others to improve their knowledge or skills.Customer/Stakeholder focused (understand business plans and operating environment)Education/experience: (The minimal acceptable level of education, work experience, and certifications necessary for employment, e.g.

advanced degree on chemistry, previous work experience on drug development)BS in Science or related field. Relevant work experience in manufacturing and/or the pharmaceutical industry may be considered in lieu of degree.Proven knowledge of Company supported application software (i.e. Microsoft Windows, Word, Excel, Power Point,)Basic math and reading comprehension skillsAbilities: (Abilities as evidenced through activities or behaviors that are similar to those required on the job, including Endo-wide competencies, mission critical segment competencies, and functional/job specific competencies, e.g. dealing with ambiguity, action oriented, self-development, and decision quality)Ability to work 1st, 2nd and 3rd shifts and overtime as requiredAbility to wear respirators and other protective equipmentAbility to climb stairs and ladders for 2nd level processingAbility to perform physical activity (ability to lift 40 lb.

without assistance)Ability to lead with a positive and credible demeanor that engenders trustAblity to build and maintain collaborative relationships between teams, departments and business units.Ability to organize, prioritize work in the face of shifting demands and tight deadlines.Knowledge: (Proficiency in a body of information that can be applied directly to accomplish a task, e.g. knowledge of pain therapy, knowledge of particular drugs)Experience and knowledge of cGMP and compliance issuesSolid understanding of all current state, federal and local standards and regulations, e.g., cGMP, GLP, OSHA, EEOC, EPA, and DEA.

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