Location: Bedford, MA
Summary of Primary Responsibilities:
Responsible for maintaining the overall stability program. Responsible for controlling sample receipt, testing, and release process, according to written procedures under cGMP conditions.
- Manages stability samples including receipt, storage and distribution to required departments
- Monitors stability windows and ensures schedule covers stability testing
- Ensures stability testing is completed within the established stability windows and as scheduled
- Ensures timely write-up and reviews of stability testing assays including populating the stability folders
- Coordinates and facilitates monthly stability meetings
- Creates and maintains stability program Key Performance Indicators (KPIs)
- Communicates effectively inter departmentally to aid with lab functions
- Works independently under general supervision and direction
- Works in compliance with CGMP’s
- Completes filing and archiving of data to off-site storage
- Supports and contributes to QC and cross functional projects as required.
- Works with all QC groups to maintain the overall function of the lab.
- Practices safe work habits and adheres to Anika’s safety procedures and
- Writing stability protocols and reports for commercial products, new Anika products and transferred Anika SRL products when required.
- Maintains control over 3rd party testing sample custody when required.
- Helps generate forms and update lab worksheets and MPS documents to ensure ease of use and cGMP compliance.
Substantial work with Microsoft Word to write protocols and reports requiring the ability to interpret results. Substantial work with Microsoft Excel requiring the ability to statistically analyze data and perform trending analysis. Helps to resolve problems related to generation of lab data, applies thorough analysis and evaluates intangible variables to reach logical conclusions. Processing received samples requiring strong organizational and administrative skills. Can work with analysts to make corrections on generated lab data.
Experience, Knowledge, and Skills Required:
- Requires lab administrative experience and understanding of theories and practices in Medical Device/Drug Product Stability
- High School Diploma/GED and 5 years’ experience in Life Sciences industry
- Experience with data trending and statistical programs (JMP, MiniTab, Excel, etc) preferred.
- Proficient knowledge in current regulations and guidance documents including cGMP, ICH, FDA, and EMA requirements.
- BS in Chemistry or other Physical Science preferred
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.