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Job Description
This position reports to Weekend Night (E) shift. This shift schedule is Saturday and Sunday 10:00 PM to 10:00 AM, plus a third day during the week. This shift requires working on all company designated holidays. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.
Summary:
Supervise, plan, organize, direct, and evaluate routine activities of Quality Laboratory to ensure the safety and reliability of Takeda products and to comply with quality and regulatory requirements.Support and make critical decisions for the release of raw materials, in-process production, and final release of finished products in a timely manner.Identify potential risks associated with laboratory operations and lead teams to resolve quality issues.Implement testing standards and policies.Manage daily operation of the lab and control of workflow to ensure operational efficiency with emphasis on results and continuous improvement.Coach lab personnel and enhance their performance.Evaluate employee performance on a regular basis.
Essential Duties and Responsibilities:
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Ensure completion of all testing, including raw materials, in-process, final release, stability, and special project/protocol testing in a timely manner that achieves fulfillment to commitments
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Implement and continuously improve quality systems to ensure compliance with testing SOPs and specification. Utilize regulatory and quality guidelines such as FDA, GLP, QSR, cGMP, USP, and CDR as guidance for these systems
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Monitor testing techniques and review accuracy of records and documentation generated
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Lead and/or support problem-solving sessions through application of the problem-solving tools and methods to coordinate and/or lead investigation teams. Will lead complex investigations (such as CAPA Assessments)
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Perform routine walkthroughs and compliance checks to verify adherence to quality guidelines. Interact with inspectors in regulatory audits to represent area of responsibility
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Lead laboratory audit-ready status efforts in understanding FDA, Baxter, and other regulatory and quality requirements. Maintain a high level of expertise in current regulatory requirements and serve as a laboratory resource for compliance to these requirements
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Proactively lead initiatives to contribute to build a strong team and increase efficiency, solve problems, resolve operational issues, generate cost savings, and improve quality
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Adhere to established expenditure controls to support management of laboratory budget
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Ensure a safe and accountable working environment for employees by adhering to company work rules, policies, and safety standards
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Make appropriate staffing recommendations through effective interviews, performance appraisals, and by driving appropriate accountability and feedback. Ensure employees have development plans. Create performance improvement plans (PIP) where necessary
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Ensure employees are properly trained and/or qualified and periodically audited. Ensure personal training requirements are met and that training records are current
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Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation
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Ensure equipment maintenance and calibration is robust and completed on time
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Work with minimal Supervision to set clear direction for all direct reports consistent with departmental needs
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Drive Lean principles such as 5S throughout daily work activities
Qualifications:
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Knowledge of operating and troubleshooting methods for lab equipment as well as quality and regulatory requirements pertinent to quality control of pharmaceutical and biological quality labs
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Must demonstrate ability to apply sound scientific principles and compliance standards to laboratory testing requirements as performed in pharmaceutical quality control laboratories
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Must demonstrate good Supervisory skills and excellent interpersonal skills for effective communication with subordinates, peers, and management
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Effective at handling and resolving personnel conflicts in a proactive manner
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Good leadership, organizational, and time-management skills demonstrating the ability to manage multiple projects and/or lab operations concurrently and effectively. Must be able to manage complex scenarios and continue to meet business commitments on time
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Must demonstrate the ability to effectively coach, mentor, and motivate direct reports, resulting in a high-performing team with a focus on results and task completion in support of operational goals
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Must demonstrate effectiveness in holding direct reports accountable for assigned tasks, work rules, and safety standards through a combination of positive and constructive reinforcement
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General knowledge of statistical techniques. Working knowledge of QSR, cGMP, CFR, USP, and GDP
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Demonstrate good technical writing skills (e.g. exception reports) and the ability to seek and identify robust mistake-proofing solutions
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Represent the laboratory through technical presentations, material review board, management reviews, and other department presentations
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Computer literate and competent with a solid knowledge of word processing and spreadsheets (such as Microsoft Office). Must be capable of preparing formal presentations
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Proficient with wide variety of lab application software
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Knowledge of applying QLP problem-solving methods
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Demonstration of basic project management skills
Education and/or experience:
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Typically requires bachelor’s degree in chemistry, biological science, or other related technical field. 5+ years of related experience. Some leadership experience preferred
Physical Demands:
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Must be able to lift, push, pull and carry up to 25 lbs
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20/20 near vision required (corrected as acceptable)
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Must be able to recognize and distinguish among the colors red, yellow, and blue
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In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility
Working Environment:
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Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas
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No make-up, jewelry, contact lenses, nail polish, or artificial fingernails may be worn in the manufacturing environment
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Will work in a cold, wet environment
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Must be able to work multiple shifts, including weekends
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May be required to work in a confined area
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Some Clean Room and cool/hot storage conditions
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Will work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection
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Must be able to work supplemental hours as necessary to complete work commitments
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Inside working conditions
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5% travel as applicable
Locations
USA – CA – Los Angeles
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time