QA Line Ops Lead (Weekend Night Shift, 7P-7A)
927 S Curry Pike Bloomington, IN 47402 Bloomington, IN 47402 US
Target Pay Rate: 70-81k **salary will be commensurate with experiencee
The Quality Assurance Line Operations (QALO) Lead is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to QALO and Manufacturing to ensure that finished products meet the required specifications by supervising QALO Sr. Technicians, Associates I, and Associates II, who provide quality oversight in the manufacturing areas. The QALO Lead provides decision making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Baxter Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The QALO Lead creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.
The work schedule for this opening is for the Weekend Shift: 7:00 PM - 7:00 AM. The shift will cover weekends and Holidays. The work schedule is 36 hours and is considered full-time. The shift may be flexible based on business need.
What you'll do:
- Provides guidance, support, direction, and leadership through positive interactions with all personnel during daily operations
- Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised
- Plans and schedules the work of QALO direct reports
- Interview, hire, train, and evaluate QALO personnel. Ensures all QALO oversight tasks are properly completed and documented
- Reviews all risk assessment results and ensures compliance
- Ensures compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety
- Tracks and trends Quality data for review/reporting and maintains visual controls and accountability tools
- Works closely with Production Supervision, Technical Services, and Engineering to ensure adequacy and appropriateness of parameters, product specifications, and overall cGMP compliance
- Leads cross functional continuous improvement project teams utilizing Lean principles
- Lead change control activities/documentation such as validation change control documents, work orders, Hold requirements, etc.
- Develops and maintains documentation procedures, QA instructions, and department policy procedures. Ensures product compliance regulations are followed
- Works in collaboration with management team to prepare for internal and external audits. Assists with timely closure of audit observations
- Represent QALO during client audits and regulatory inspections, as needed. Provide information as needed to auditors that establishes credibility and demonstrates compliance with cGMPs
- Performs quality review of Nonconformance Reports, procedures, risk assessments/static pressure events, environmental chamber charts, batch record and SOP revisions, and validation documents, as necessary
- Provides technical support and guidance to Nonconformance Report authors
What you'll bring:
- Bachelor’s degree (in a science field preferred)
- Minimum of 3 years of proven experience in Pharmaceutical Quality or Manufacturing, management experience preferred
- Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required.
- Knowledge of aseptic manufacturing processes preferred.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Maximo, Trackwise, etc.)
Physical / Safety Requirements
- Must wear appropriate PPE as the need arises for various manufacturing areas
- Must be able to gown qualify for Grade A/B areas.
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position requires sitting for long hours, but may involve walking or standing for periods of time.
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