Quality Supervisor - Filling

Simtra BioPharma Solutions•Bloomington, IN

8d•Onsite

About The Position

Simtra BioPharma Solutions is a Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in the US and Germany, they offer a wide range of delivery systems and product types, focusing on quality and continuous improvement to meet the highest regulatory standards. The Quality Supervisor is part of the Quality Assurance Leadership Team, reporting to the Senior Manager, Quality. This role provides direct support to Environmental Monitoring, QALO, and Manufacturing to ensure finished products meet specifications by supervising QALO personnel. The position involves decision-making and oversight for regulatory compliance and Simtra's Standard Operating Procedures, driving quality operations on the production floor and fostering teamwork, productivity, safety, and quality in the finished product.

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.