Planet Pharma
6-month contract to hire
2nd shift Tuesday-Friday (2:30PM – 12:30AM); 10% shift differential
Level I- $38/hr, could potentially level up to level II depending on experience
The Specialist I is responsible for day-to-day Quality Assurance Operations activities in accordance with cGMPs, CFRs, ICH guidelines and company policies and procedures. The Specialist I will work onsite alongside manufacturing and quality control personnel, helping to ensure that the highest standard of work is performed. This individual is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.
The Specialist I will support Quality Assurance lot release and disposition activities including process observation, batch record review, and completion of lot release documentation. The Specialist I supports Quality Assurance initiatives including, but not limited to, review of laboratory investigations and deviation investigations. The successful candidate will support internal teams and be able to effectively communicate bi-directionally in a complex, changing, and fast-paced environment.
Essential Functions and Responsibilities
Quality Assurance Operational Support:
- Perform QA Operations activities that include review of manufacturing batch records and labeling/packaging operations to ensure timely release of cell therapy products.
- Support quality assurance processes, controls and batch history files for QA Operations and Lot Disposition
- Perform real-time, on-the-floor support for manufacturing production activities to ensure compliance with GMP and GDP quality initiatives, escalating issues as required.
- Track and communicate standard work completion and hurdles.
- Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
- Maintain a collaborative and professional relationship with CMOs.
- Release of raw materials and inventory.
- Prepare and organize release documentation for approvals.
- Support internal audits and regulatory
Subject Matter Expertise:
- Support the efficient and timely review of laboratory investigations and deviation investigations.
- Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
- Experience with cell therapy products and/or relevant skills.
General:
- Ability to work effectively on multiple projects simultaneously
- Excellent oral and written communication skills
- Must possess a high level of attention to detail
- Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
- Strong computer, organizational, and compliance Proficient with Microsoft Office Suite, Word, Excel, and PowerPoint
- Must be comfortable in a fast-paced environment with changing priorities.
- Support QA and Logistics activities for on-going projects.
- Assist with implementing GMP QA procedures
- Other duties as assigned.
Required Education, Skills, and Knowledge
- BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college.
- At least 2 years demonstrating proficient GMP QA/QC experience.
- Experience with use of an electronic QMS (i.e. MasterControl, Veeva)
- Familiarity with Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
- Knowledge of GMP, Good Documentation Practices (GDP) and FDA quality systems.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to perform cleanroom gowning and pass gowning qualification.
- Must meet requirements for and be able to wear a half-face respirator
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines
