Process Engineer, STAQ Pharma In Denver, CO
- Safety, transparency, availability and quality in compounded medications
Title: Process EngineerJob Type: Full-time
- Bachelor's (Required)
- cGMP environment: 2 years (Preferred)
- The Process Engineer will be part of our cross-functional team that continuously seeks to improve, develop, design and implement processes that meet or exceed our delivery, quality and cost expectations.
- Lead all Quality Control activities.
- Encourage and motivate associates to be successful and focused on Safety, Transparency, Availability, and Quality (STAQ) objectives.
- Work with all departments to develop procedures/documentation, implement issue reporting and resolution processes, implement continuous improvement, and provide support on all Quality Control activities.
- Develops, manages, and improves Quality Control processes and procedures to ensure compliance with all applicable laws, regulations, and STAQ Quality standards in support of cGMP standards for pharmaceutical manufacturing (503B).
- Focuses on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions.
- Oversees process for laboratory analysis of raw materials, in-process QC, finished goods release testing, and reserve sample management.
- Participates in internal/external audits and regulatory inspections.
- Gains feedback from the clients, attending meetings, submitting reports, and assisting external auditors and inspectors.
- Leads the Stability Program including study management, protocol development & evaluation, timely completion of stability tests, data trending, etc.
- Identify and devise ways to improve the operations process to ensure higher-quality processes and products.
- Ensures investigations related to OOS/OOT, unexpected results, adverse trends, or invalids are performed appropriately and within expected time frames.
Detail Information and To ApplySee Process Engineer, STAQ Pharma
Also Contact: Anil Mathai, Director of Quality & Compliance
- Mobile: 720-560-6179
- Email: email@example.com
- Subject: Job: Process Engineer