Quality Associate I - Filling (weekend third shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Associate I to join their Quality Assurance team. This role is crucial for maintaining the highest standards of quality in the manufacturing of sterile injectable products. You will work closely with manufacturing personnel, ensuring compliance with regulatory requirements and contributing to a culture of continuous improvement. The position supports a weekend third shift schedule, allowing for flexibility while ensuring that quality and safety are prioritized. Join a forward-thinking company dedicated to excellence in the pharmaceutical sector and make a significant impact on patient safety and product integrity.

Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Education Assistance Program

Paid Time Off

Flexible Spending Accounts

Employee Assistance Program

Community and Volunteer Service Program

Short and Long-Term Disability Insurance

Adoption Reimbursement Program

Onsite Campus Amenities

Qualifications

• Must ensure compliance with regulatory agency requirements.
• Experience in Pharmaceutical Quality/Manufacturing is essential.
• Ability to perform quality functions in classified areas.

Responsibilities

• Maintain quality oversight during manufacturing processes.
• Perform in-process review of records for compliance.
• Collaborate with teams for audits and corrective actions.

Skills

cGMP Compliance

Good Documentation Practices (GDP)

Quality Assurance

Aseptic Processing

Regulatory Knowledge

Team Collaboration

Education

BS degree in Science (preferred)

AS degree with 1 year of experience

2 years of experience without degree

Tools

MS Office Suite

Enterprise Software (JDE)

Job description

Quality Associate I - Filling (weekend third shift)

Bloomington, Indiana, United States

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.

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 3rd 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 2030 to 0930 on Saturday/Sunday and 2030 to 0730 on Thursday/Friday or Monday/Tuesday, as applicable. The work schedule is 36 hours and is considered full-time. The shift may be flexible based on business needs.

The responsibilities:

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety
• In-process 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 bi-annual 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
• 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 210,211 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, you’ll be eligible for:

• 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

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.

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.