Job Description:

The QC Specialist II Insulin will join the Civica, Inc. organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic, insulin, and biosimilar sterile injectable medications. Responsibilities of the position include performing analytical testing on sterile injectable products. Responsibilities also include maintenance of analytical equipment and executing method verification, validations, and transfers. 

The role is essential to ensure the intended materials are utilized for manufacturing and meet the required standards to ensure the finished product meets the applicable standards of identity, strength, quality, and purity. You will help Civica achieve its mission of delivering quality medicines that are available and affordable to everyone by complying with applicable regulatory standards (e.g., Current Good Manufacturing Practices, and FDA Guidance documents) and expectations for the development and reliable supply of quality medicines.

Essential Duties and Responsibilities:

• This position will focus on the needs of the Insulin project and all activities required to support this product.
• Perform analytical testing and interpret and document actions and results using proper documentation practices.
• Participate in analytical method transfers and perform method verifications/validations.
• Notify management of OOS, OOT or atypical results on the day of discovery with the appropriate level of urgency.
• Lead and/or participate in laboratory investigations.
• Ability to complete HPLC analysis with minimal supervision. Experience with Empower software, and diode array and single quad detection experience is a plus.
• Maintain LIMS data.
• Contribute to and promote a safety culture by adhering to established safety procedures, engineering controls and appropriate PPE.
• Maintain a clean and organized work environment in accordance with 6S lean principles.
• Inform management of continuous improvement and opportunities
• Lead and/or participate in 6S and OPEX initiatives
• Ability to work independently or in a team setting effectively.
• Complete chemical inventory and order supplies as required.
• Conduct other duties as required by management.

Basic Qualifications and Capabilities:

·      Bachelor’s degree in a scientific discipline with at least 8+ years’ experience working in the pharmaceutical industry.

·      Proficiency with LIMS software, analytical data acquisition software, and Microsoft Office® applications, including Excel, Word, and PowerPoint.

·      Ability to multi-task and change priorities in a fast-paced environment.

·      Self-motivated and willingness to learn and help others.

·      Working knowledge of relevant FDA and ICH guidelines and USP requirements.

·      Wet chemistry testing by USP methods, pH, conductivity, atomic absorption, and loss on drying.

·      Proficient in HPLC analyses.

·      Prepare and/or review technical documents such as protocols, reports, SOPs, and testing procedures.

·      Analytical method transfers, method verifications, and validations.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. 

The company is an equal opportunity employer, a drug-free workplace, and complies with ADA regulations as applicable.