Description
Review batch records for timeliness and accuracy. Perform final review of manufacturing documentation across multiple production lines and support area for compliance and release.
Essential Functions
Evaluate, report and prepare data from documentation errors to management for trending and training; prepare and maintain MOS for all departments on monthly basis
Review production batch records and related documents for accuracy and completeness
Perform reconciliation of product yields after completion of manufacturing and/or packaging
Preparing production batch records with in-process labels, forms and other related documents needed to process, evaluating inventory cards and submitting to pharmacy
Maintain all production logbooks (ordering new logbooks, and sending completed to document control with tracking record) and communicating with document control for batch records, logbooks and other documents
Review R&D batch records
Review and update JDE entries and provide lot status updates to manager
Co-ordinate with production planning department for work order, support internal/external audits as requested
Additional Responsibilities
Perform additional duties as requested. Participate in and support continuous improvement activities, maintain a clean and organized work space area to ensure compliance.
Education
High School or GED - Required
Experience
3 years or more in Manufacturing or Packaging
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Skills
Ability to read, write and communicate in English at a level to facilitate the understanding of the terminology of the job - Advanced
Ability to comprehend and follow written and verbal procedures/instructions - Advanced
Computer Knowledge (Excel and Power Point) - Advanced
Have basic math and mechanical skills - Advanced
Specialized Knowledge
Competent knowledge of SOP's and cGMP's
Good problem-solving skills
Flexibility to rapidly adjust to changing job requirements
Good communication skills
The hourly rate for this position ranges from $20.50 to $26.50 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
