Quality Lab Associate I (3rd Shift)
Simtra BioPharma Solutions
Summary
The Quality Lab Associate I performs entry-level laboratory testing that requires a variety of chemical, biological, or physical analyses on products in support of the company's quality program. This role works as part of the quality unit. This position reports to a Chemistry Analytical Supervisor.
Job description
The role
The Quality Lab Associate I performs entry-level laboratory testing that requires a variety of chemical, biological, or physical analyses on products in support of the company's quality program. This role works as part of the quality unit. This position reports to a Chemistry Analytical Supervisor.
The responsibilities
- Operates applicable laboratory equipment such as HPLC, UV, Karl Fischer, pH meter, density meter, etc.
- Performs testing in accordance with applicable Standard Operating Procedures (SOP's).
- Performs testing on raw material lots, in-process products, and finished product batches as required on the associated documentation.
- Maintains data integrity and ensures compliance with company SOP's and worldwide regulatory agency requirements.
- Initiates Laboratory Investigation Reports.
- Uses the US, EU, and Japan pharmacopeias (USP, EP and JP).
- Participates in continuous improvement activities that increase efficiency, solve problems, generate cost savings, and improve quality.
- Performs internal laboratory checklist and audits.
- Perform general laboratory/personal area clean-up.
The requirements
- Bachelors degree in a physical science required
- Accurate and thorough with attention to detail.
- Work in a courteous and professional manner with interior and exterior clients.
- Strong communication skills, verbal, non-verbal and written, are required.
- Computer proficiency in Microsoft software programs and the ability to learn and use enterprise software.
Physical / Safety Requirements
- Must be able to wear personal protective equipment.
- Duties may require overtime work, including nights and weekends.
- Use of hands and fingers to manipulate office equipment is required.
- Position may require sitting or standing for long periods of time.
- This position requires handling of laboratory chemicals.
- Must be able to qualify for 20/40 corrected vision.
Requirements
- Bachelors degree in a physical science required
- Accurate and thorough with attention to detail
- Work in a courteous and professional manner with interior and exterior clients
- Strong communication skills, verbal, non-verbal and written
- Computer proficiency in Microsoft software programs and ability to learn enterprise software
- Must be able to wear personal protective equipment
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment
- Position may require sitting or standing for long periods of time
- This position requires handling of laboratory chemicals
- Must be able to qualify for 20/40 corrected vision
Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Matching
- Paid Holidays
- Paid Time Off
- Paid Parental Leave
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Short and Long-Term Disability Insurance
- Vision Coverage
- Accident Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal Benefits
- Onsite Workout Facility
- Onsite Cafeteria
- Onsite Credit Union
Company overview
Simtra BioPharma Solutions is a premier, independently owned Contract Development and Manufacturing Organization (CDMO) specializing in sterile injectable medicines. With over 65 years of manufacturing experience, the company offers world-class cGMP sterile fill/finish services, technical expertise, and quality solutions for pharmaceutical and biotech clients. Headquartered in Parsippany, New Jersey, with additional facilities in Bloomington, Indiana and Halle, Germany, Simtra provides comprehensive development and manufacturing services for parenteral products including prefilled syringes and vials. The company serves clients facing formulation challenges, clinical supply hurdles, market demand fluctuations, or risk mitigation concerns, offering tailored solutions to accelerate time-to-market. As a full-service CDMO, Simtra supports clients from clinical development through commercial launch with expertise in aseptic operations, quality systems, and global regulatory compliance. The company is currently implementing a $250+ million expansion at its Bloomington facility to enhance syringe fill lines and lyophilization capabilities.