Quality Supervisor - Filling (weekend AM)

Simtra BioPharma Solutions•Bloomington, IN

4d•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. This role: The Quality Associate III (Quality Supervisor), Quality Assurance Line Operations (QALO) is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager. They provide direct support to 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. This position supports Weekend AM Shift: The Weekend Shift is responsible for weekends and Holidays in addition to flexible workdays on Thursday/Friday or Monday/Tuesday. The hours are from approximately 0700 to 1930 on Friday/Saturday and 0700 to 1930 on Sunday/Monday, as applicable. The work schedule is 36 hours and is considered full-time. The shift may be flexible based on business needs.

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: Microsoft Dynamics, SAP, Veeva, TrackWise, 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 A/B areas.
Duties will require overtime work, including off-shift hours and Holidays as required.
Use of hands and fingers to manipulate office equipment is required.
Position requires sitting for long hours but may involve walking or standing for periods of time.

Responsibilities

Able to successfully perform all the primary responsibilities of QALO personnel (ex, providing quality oversight, chart review, etc.).
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.
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 FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements.