Quality Associate II - Filling 3rd 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 II is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Line Operations (QALO) Lead. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during the manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures (SOPs). They facilitate training of new Quality Associates in QALO. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork productivity safety identity strength purity and quality (SISPQ) are reflected in the finished product. The role may also support CAPEX/expansion projects for manufacturing representing Quality on crossfunctional project implementation teams. This position is on 3rd shift (Sunday Thursday 10:30pm 7:30am).

What youll be doing:

• Facilitates training qualifications and ongoing support for associates including activities such as aseptic intervention oversight room inspections oversight checklists and equipment chart review
• Leads cross functional continuous improvement project teams utilizing Lean principles
• Serves as principal quality author for significant nonconformance (potential batch impact) reports
• Provides technical support and guidance to nonconformance authors
• Acts as team leader to shift associates in absence of supervisor
• Assists supervisor in maintenance of visual controls and accountability tools
• Ensures compliance with all federal state local and companyspecific regulations related to quality of product and employee safety
• Reviews records to ensure they are complete accurate and compliant with current Good Manufacturing Practices (cGMP) requirement including batch records and other documents involved in the aseptic processing of drug product
• Reports errors deficiencies discrepancies and observations to management
• Performs Quality functions in classified areas including checklists and aseptic intervention oversight
• Initiates and reviews proposed standard operating procedure (SOP) revisions
• Works in collaboration with management team to prepare for internal and external audits and assists with timely closure of audit observations

What youll bring:

• BS degree (preferred science discipline) and 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience or AS 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
• Working knowledge of FDA CFR 210211 and other applicable regulations and Good Documentation Practices (GDP) required
• Intermediate (or higher) proficiency in MS Office Suite (Word Excel and Outlook)
• Ability to use and understand enterprise software (i.e. JDE)

Physical / safety requirements:

• Must wear appropriate PPE as required 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 standing for long hours but may require sitting 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.

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