Quality Supervisor - Filling (weekend PM)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 公司

Paid Holidays

Paid Time Off

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Supervisor to join the Quality Assurance Leadership Team. Reporting to the Quality Manager, you will oversee QALO personnel on the production floor, ensuring finished products meet specifications and regulatory guidelines.

You will collaborate with Manufacturing and cross-functional teams, drive quality improvements, and uphold SISPQ principles, with a schedule of Friday evening to Monday morning shifts and overtime as needed for

Qualifications

• Bachelor’s degree (preferred science discipline) plus 2 years in Pharmaceutical Quality/Manufacturing or 3 years with Associate’s degree.
• Minimum 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and GDP; Good Documentation Practices required.
• Knowledge of aseptic manufacturing processes is required.
• Proficiency with MS Word, Excel, Outlook and enterprise software (examples: D365, Blue Mountain, Veeva).

Responsibilities

• Perform the primary responsibilities of QALO personnel.
• Grow, manage, develop and evaluate QALO personnel including hiring.
• Provide rapid, quality-first decision-making with manufacturing and cross-functional teams.
• Ensure training and compliance of QALO associates and Quality Technicians.
• Draft and approve investigation/deviation reports.
• Lead daily QALO activities and assist cross-functional areas.
• Ensure tasks are completed to meet Quality and site metrics.
• Draft, revise and review SOPs, batch records and related documentation.
• Ensure compliance with federal, state, local regulations and safety policies.
• Lead and participate in process/product improvement projects and validations.
• Support audit readiness and stay current with regulatory requirements.

Skills

Leadership

GXP/Regulatory Knowledge

Aseptic manufacturing

Quality oversight

Problem solving

Communication

Education

Bachelor’s degree (preferred science)

Associate’s degree

No degree with 5+ years experience

Tools

D365

Blue Mountain

Veeva

Microsoft Word

Excel

Outlook

Job description

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.

This 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.

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.

The role:

The Quality Supervisor is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to Quality Operations (QALO) and Manufacturing to ensure that finished products meet the required specifications by supervising QALO personnel, who provide quality oversight in the manufacturing areas. The QALO Associate III provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, management, and other cross-functional departments. The QALO Associate III creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The working hours for this role are Friday (evening) – Monday (morning) 1900 - 0700

The responsibilities:

• Able to successfully perform all the primary responsibilities of QALO personnel.
• Effectively grows, manages, develops and empowers QALO personnel including hiring and evaluation of performance.
• Provides rapid, quality-first decision-making in collaboration with manufacturing and other cross-functional teams.
• Ensures training and compliance of QALO associates and Quality Technicians.
• Authors and approves investigation/deviation reports.
• Leads ongoing daily QALO activities and assist other cross-functional areas to ensure successful execution/implementation.
• Ensures tasks are completed assigned to self and QALO personnel to ensure Quality and site metrics are met.
• Author, revise, and review, written standard operating procedures (SOPs), batch records, and other documentation as needed to meet Corporate, Plant, Regulatory Requirements, etc. while supporting continuous improvement initiatives.
• Ensure compliance with all federal, state, local and company-specific regulations related to quality of product and employee safety.
• Participate and lead multiple process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies or improving existing methodologies, data generation, report development, and presentation.
• Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding regulatory and Simtra quality requirements. Maintain a high level of expertise in current regulatory requirements.

Required qualifications:

• Bachelor’s 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.
• Minimum of 2 years of leadership experience.
• Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP) required.
• Knowledge of aseptic manufacturing processes are required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Blue Mountain, Veeva, etc.)
• Strong technical, analytical, and problem-solving skills.

Physical / Safety Requirements:

• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade C/D areas.
• Duties may require overtime work, including off-shift hours and Holidays as required.
• Use of hands and fingers to manipulate office equipment is required.

In return, you’ll be eligible for[1]:

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life 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
• Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • 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 12/31/26

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.