Specialist II, Quality Assurance in Edinburgh, Indiana at Sentry BioPharma Services Inc

We are seeking a detail-oriented and proactive Quality Assurance Specialist II to join our team. This role offers an exciting opportunity to contribute to maintaining the highest standards of quality and compliance within our organization. The successful candidate will play a key role in supporting our Quality Management System, ensuring adherence to cGMP regulations, and fostering continuous improvement across operational, validation, maintenance, and laboratory functions.

Key Responsibilities:

• Independently author, revise, review, and approve Standard Operating Procedures (SOPs), Client Operating Protocols (COPs), Policies, and training materials.
• Author, review, and approve GMP and non-GMP records, including preventative maintenance, pest control, and facility walk-through documentation.
• Lead Corrective and Preventive Action (CAPA) initiatives, including authoring, tracking, and verifying the effectiveness of CAPA activities.
• Track and drive the completion of assigned functions within the Quality Management System in accordance with cGMP, regulations, and company standards.
• Provide support, guidance, and recommendations regarding compliance of operational, validation, maintenance, and laboratory tasks.
• Ensure timely completion of quality-related activities and escalate issues as necessary to maintain compliance and quality standards.

Join our dynamic team and be part of a company committed to innovation, quality, and continuous growth. We offer a supportive environment that values professional development and recognizes your contributions to our success.

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• Minimum of 2-4 years of experience in Quality Assurance within a regulated environment, preferably in the pharmaceutical or biotech industry.
• Proficient knowledge of Microsoft Office (Word, Excel, Outlook), web browsers, barcoding systems, electronic Quality Management Systems (eQMS), and quick ability to learn new software.
• Strong knowledge of cGMP regulations, quality systems, and validation processes.
• Proven ability to author, review, and approve quality documentation and records.
• Excellent organizational skills with the ability to manage multiple projects simultaneously.
• Strong communication skills, both written and verbal.
• Detail-oriented with a focus on accuracy and compliance.
• Ability to work independently and collaboratively within a team.