Quality Line Operations Lead

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This Role

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. This position is on 2nd shift.

The Responsibilities

• Provide guidance, support, direction, and leadership through positive interactions with all personnel during daily operations
• Report errors, deficiencies, discrepancies and observations to management and has the ability to stop operations when product safety is/may be compromised
• Plan and schedule the work of QALO direct reports
• Ensure all QALO oversight tasks are properly completed and documented
• Review all risk assessment results and ensures compliance
• Ensure compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety
• Track and trend quality data for review/reporting and maintains visual controls and accountability tools
• Work closely with Production Supervision, Technical Services, and Engineering to ensure adequacy and appropriateness of parameters, product specifications, and overall cGMP compliance
• Lead 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.
• Develop and maintain documentation procedures, QA instructions, and department policy procedures. Ensures product compliance regulations are followed
• Work in collaboration with management team to prepare for internal and external audits and assist with timely closure of audit observations
• Represent QALO during client audits and regulatory inspections and provide information to auditors that establishes credibility and demonstrates compliance with cGMPs
• Perform quality review of Nonconformance Reports (NCR), procedures, risk assessments/static pressure events, environmental chamber charts, batch record and SOP revisions, and validation documents
• Provide technical support and guidance to NCR authors
• Interview, hire, train, and evaluate QALO personnel
  
  

Desirable Qualifications

• BS degree (preferred science discipline) and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or Associate’s degree with at least 3 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 5 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• 2+ years experience in a supervisory/leadership role
• Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP)
• Knowledge of aseptic manufacturing processes preferred
• Attention to detail and ability to stay organized
• Intermediate (or higher) proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Ability to use Enterprise software (JDE, SAP, 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
• Position requires sitting for long hours, but may involve walking or standing for periods of time
  
  

In return, you’ll be eligible for [1]:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Additional Benefits
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union
  

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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