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QA Line Ops Lead (Weekend Night Shift, 7P-7A)

Bloomington, IN 47402

Posted: 01/09/2024 Employment Type: Direct Hire/Perm Job Number: 591299 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 70-81k **salary will be commensurate with experiencee


Job Description: 

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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Bloomington, IN

Discover exciting job opportunities in Bloomington, Indiana! Nestled in the heart of the Hoosier State, Bloomington offers a vibrant community, a thriving arts scene with venues like the Buskirk-Chumley Theater and the Eskenazi Museum of Art, and a bustling downtown area filled with charming shops and unique restaurants serving up delicious farm-to-table cuisine. Home to Indiana University, a top-tier educational institution, Bloomington provides endless growth opportunities and a welcoming atmosphere for professionals looking to advance their careers. Don't miss the chance to be part of this dynamic city, explore our job listings today and kickstart your career in Bloomington!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.