To begin the application process, please enter your email address.
Company Contact Info
- Richmond, VA
Sorry, we cannot save or unsave this job right now.
Report this Job
Saving Your Job Alert
Job Alert Saved!
Could not save Job Alert!
You have too many Job Alerts!
Email Send Failed!
Stability Specialist I
Fareva • Richmond, VA
Posted 1 month ago
Stability Specialist I
Fareva is currently seeking an experienced Stability Specialist I to join our team in Richmond, VA.
Who we are:
Fareva is a leading contract manufacturer of pharmaceutical and personal care products. Located at intersection of Darbytown Road and Laburnum Avenue in Eastern Henrico County. Employs 600 full time employees. Comfortable climate controlled facility covering over 745,000 square feet.
About the role:
The position requires a working knowledge of ICH and FDA stability regulations, as well as, plant and laboratory systems and procedures. The individual contributes to a variety of routine and non-routine tasks performed in accordance with cGMP’s. Primary tasks include development, scheduling, management and analysis of stability studies in support of business objectives and regulatory requirements. The individual is capable of recognizing and acting on stability related concerns and provides support as needed to resolve issues using supervision, SOP and regulatory guidance.
What you'll do:
Document & Sample Management
- Manages routine and non-routine stability protocols and studies according to departmental and site document control procedures
- Works collaboratively to ensure stability samples are labeled, placed in storage, pulled and submitted to the laboratories in a timely manner
- Generates, files and coordinates NDA and Non-NDA stability summary reports containing completed and approved data and study information.
- Prepares quality stability reports and supports regulatory submission requirements.
- Submits customer reports upon request
- Maintains 5s and supports process improvement efforts
Stability Requirements and Protocol Initiation and Management
- Works cross-functionally with planners and plant personnel to manage the stability annual requirements. Orders stability samples and confirms annual product and customer commitments are complete.
- Drafts routine and non-routine stability protocols to support stability commitments and special projects
- Builds stability studies and coordinates samples movements based on stability requirements
- Creates, updates, reviews and approves SOPs, reports, summaries and special project documents
- Maintains personal training curriculum attainment
- Supports job training and provides guidance for new hires
- Supports Event notifications and CAPA as the Stability SME
- Supports change control activities for relevant stability related changes as needed
- Assures compliance to all applicable safety policies, procedures and practices.
- Supports environmental monitoring activities (e.g. perform checks, manage alarms, coordinate repairs
- Supports environmental monitoring responsibilities as the SME or designee
Annual Product Reviews (APQR)
- Assists the Stability Statistician or designee with Annual Product Review analyses for all marketed products (e.g. reviews OOS results, time point verification, data collections, etc.).
- Reviews APQR trend reports
Our ideal candidate:
Education and experience
- BS in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline. 2 + years of relevant Quality experience preferably in the bio/pharmaceutical industry.
- Experience with and knowledge of ICH and FDA stability regulations and guidelines
- Ability to work independently and in a group environment
- Strong verbal and written communication skills
Skills and abilities:
- Human Skill – ability to work with others
- Technical Skill – Knowledge of SAP and the laboratory LIMS system. Possesses understanding and is proficient in stability related concepts and standard practices
- Conceptual Skill – ability to interpret meaning of stability data as it applies to product performance and operations.
What we offer:
Competitive salaries, comprehensive health/vision/dental insurance, company paid short term disability, company paid life and accidental death insurance (after 30 day waiting period), 401(k) plan match of 4.5% with immediate vesting, generous employee referral program, 12 days of vacation annually, 12 paid holidays annually, onsite cafeteria, job advancement opportunities. Manufacturing employees also receive company paid work shoes, uniforms and prescription safety eyeglasses.
Please submit your resume via the "APPLY NOW" button