Stability Coordinator (PERM)
Newton, MA 02453
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Stability Coordinator
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Perm
- Pay rate: $90k
- Job Location: Newton, MA
- Job#: bh14248
Essential Duties and Responsibilities:
Responsible for maintaining the overall stability program. Responsibilities include, author stability protocols, reports, data trending, maintenance of data table to support stabilities studies and shelf-life activities. Responsible for controlling sample receipt, testing, and release process.
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.
• Writing stability protocols and reports for commercial products, new products and transferred products when required.
• Management of stability samples, including receipt, study initiation and storage
• Monitors stability windows and ensures schedule covers stability testing requirements
• Ensures timely write-up and review of stability testing assays including populating the stability folders and associated spreadsheets
• Coordinates and facilitates monthly stability meetings
• Creates and maintains stability program Key Performance Indicators (KPIs)
• Communicates effectively inter/intra departmentally to aid with lab functions
• Works independently under general supervision and direction
• Works in compliance with ISO:9001 and has clear and in-depth understanding of ICH guidelines related to starting and maintaining a stability program.
• Supports and contributes to QC and cross functional projects as required.
• Works with all QC groups and R&D groups to maintain the overall testing procedures required of the stability program.
• Practices safe work habits and adheres to safety procedures and procedures
Education and/or Work Experience Requirements:
· Bachelor's degree with 5-7 years in a biotechnology discipline or MS 1 – 2+ years.
· 1 - 2 years of experience in a cGMP/GxP environment is preferred.
· Requires lab or lab-related administrative experience and understanding of theories and practices in Drug/Product Stability
· Previous experience with stability studies and with data trending and statistical programs (JMP, MiniTab, Excel, etc) highly desired.
· Proficient knowledge in current regulations and guidance documents including ISO, ICH, USP, and other applicable regulatory guidance (US and EU).
· Ability to succeed in a team-oriented environment under very dynamic conditions. Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
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