Data Reviewer, QA for QC

Pii is growing! We currently have approximately 250 people on the team and plan to almost double that over the next few years as we support our growing client base. We want to add more people who have energy and enthusiasm, are looking for a challenge, and want to drive significant change. If you want the reward of major professional development and growth in a smaller organization while learning valuable new skills in a cutting-edge pharmaceutical development and manufacturing organization Pii may be the place for you.

Job Summary:

The QC Data Reviewer I ensures Quality Assurance, Compliance with cGMP (current Good Manufacturing Practice), and Internal Policies, Procedures, and Specifications. This position is responsible for performing the role of QA (Quality Assurance) of QC (Quality Control) in the following functions: Data Reviewer of Chemistry Quality Control, Quality Systems, and Compliance in accordance with cGMP and related company SOPs, state, FDA, local laws and international (e.g., EU, Chinese, Japanese) as applicable.

Duties/Responsibilities:

• Review various analytical chemistry testing data by using equipment, techniques, and software, e.g.,
  1. High-performance Liquid Chromatography (HPLC)
  2. Gas chromatography (GC)
  3. Dissolution
  4. Integrated Software Empower 3.
  5. UV-Vis Spectrophotometer
  6. Mastersizer 3000 for Particle Size Distribution (PSD)
• Data Review of Analytical Chemistry Testing:
  1. Raw Material (RM) including API (active pharmaceutical ingredients) and excipients
  2. In Process (IP) Testing
  3. Clinical Verification
  4. Packaging Material
  5. Components
• Review the data to Comply with GLPs, cGMPs, and GDP (Good Documentation Practice).
• Continuously improve and educate analytical chemists to improve analytical data reporting, adhering to GDP and cGMP to increase efficiency, compliance, and Quality.
• Review analytical data to ensure ALCOA+.
• Ensure compliance of testing with laboratory procedures, test methods, and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus, and multitask on review of analytical laboratory data.
• Adhere to the Safety and Health Program and associated plans.
• Review time of use logs on cGMP instrumentation and other analytical equipment.
• Completion of work within the assigned time frame, to perform or assist in general organizational tasks including open tasks and timelines and tracking of tasks.
• Knowledge of QA events/deviations/Investigations.
• Interaction with QC Analysts and other departments as needed
• Any other responsibilities are assigned by the manager or department head.

Required Skills/Abilities:

• Demonstrates excellent personal organizational skills
• Knowledgeable in Pharmaceutical industry regulations
• Health and Safety Awareness
• Must work as a team member in the QC Lab environment

Education and Experience:

• Bachelor’s degree or higher, in Chemistry, Pharmacy, Sciences, or Quality (QA/QC), or equivalent work experience
• 0-3 years of relevant work experience in Quality Assurance/Data review of Chemistry QC in the pharmaceutical industry.
• Experience in all areas of Pharmaceutical, e.g., CMO, CDMO, Clinical and commercial products is preferred.
• Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project, Proofreading skills, etc.
• Knowledge of Quality Management Systems such as Master Control.
• Knowledge of current federal, local, and international regulations regarding the Testing, production, and release of drug substances and products.
• Ability to manage multiple priorities and re-prioritize tasks as required.
• Excellent problem-solving skills.

Physical Requirements:

• Fluent in English

• Ability to travel between and within facilities to visit staff, operations, projects, etc.

• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

• Ability to lift up to 40 pounds on occasion.

• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).