Quality Associate III - Filling weekend 2nd shift

Simtra BioPharma Solutions (Simtra) is a worldclass 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 prefilled syringes liquid/lyophilized vials diluents for reconstitution powderfilled 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 lifechanging 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 teamsso we can solve problems in new ways.

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

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

This role:

The Quality Associate III 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 supports Weekend 2nd Shift: The Weekend Shift is responsible for weekends and Holidays in addition to flexible workdays on Thursday/Friday or Monday/Tuesday. The hours are from 1330 to 0030 on Saturday/Sunday and 1430 to 2330 on Thursday/Friday or Monday/Tuesday as applicable. The work schedule is 36 hours and is considered fulltime. The shift may be flexible based on business needs

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 companyspecific 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 Associates 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 210211 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 youll 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 LongTerm 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.

EEO is the Law
EEO is the law Poster Supplement
Pay Transparency Policy

Data Privacy

To learn more about Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy:

Experience:

IC