For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.
In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.
It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.
Your role at Simtra BioPharma Solutions:
The Quality Associate I Line Operations is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Supervisor. 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 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.
What you'll do:
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 to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
Reports errors, deficiencies, discrepancies and observations to management. May stop operations 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. Assists with timely closure of audit observations and CAPAs.
Initiates and authors Nonconformance Reports and corrective and preventative action responses.
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.
What you'll bring:
Bachelor’s degree (preferred science discipline), or Associate’s degree with at least three years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least six years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
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 will require overtime work, including scheduled weekend shifts
Use of hands and fingers to manipulate office equipment is required
Position requires standing for long hours, but may require sitting for periods of time.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment Opportunity
Simtra is 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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.