Quality Associate I - Filling weekend second 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 I is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Line Operations Lead. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during 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. 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.

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 respectively. The hours are from 1330 to 0330 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:

• Ensures compliance with all worldwide regulatory agency requirements and companyspecific regulations related to quality of product and employee safety
• Inprocess review of records (batch records and other documents involved in aseptic processing of drug product) to ensure they are complete accurate and compliant with current Good Manufacturing Practices (cGMP) requirements
• Reports errors deficiencies discrepancies and observations to management and provide direction to halt operations if/when product safety is or may be compromised
• Performs quality functions in classified areas including production oversight manufacturing process assessments and aseptic intervention oversight
• Works in collaboration with management teams to prepare for internal and external audits and assists with timely closure of audit observations and corrective and preventative action responses (CAPAs)
• Initiates and authors nonconformance reports (NCRs) and CAPAs
• Conducts biannual inspections of classified areas in preparation for facility shutdown periods
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement
• Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation

Desirable qualifications:

• BS degree (preferred science discipline) or AS degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience or no degree with at least 2 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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