Quality Supervisor - Filling (weekend AM)

Simtra BioPharma Solutions•Bloomington, IN

9d•Onsite

About The Position

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. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. The role: The Quality Supervisor is a member of the Quality Assurance Leadership Team reporting directly to the Senior Manager, Quality. They provide direct support to Environmental Monitoring, 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 Quality Supervisor 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 Quality Supervisor creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. The working hours for weekend AM are Friday, Saturday, and Sunday 7a-7:30p

Requirements

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.
Good interpersonal/communication/influencing/negation skills.
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.
Must wear appropriate PPE as required for various manufacturing areas
Must be able to gown qualify for Grade C/D areas.

Nice To Haves

Experience with environmental monitoring preferred.
Familiarity with isolator filling machines highly preferred.

Responsibilities

Able to successfully perform all the primary responsibilities of EM and QALO personnel.
Effectively grows, manages, develops and empowers 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 and environmental monitoring 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.