Stability Associate II with Pharmaceutical Company!

Kelly Scientific Resources, the global leading in the scientific staffing field, is seeking a Stability Associate II for their pharmaceutical client located in Fort Collins. The ideal candidate should have a Bachelors degree in Chemistry combined with 0-2 years pharmaceutical analytical experience. Emphasis on methods development and validation is strong asset.

As a Stability Associate II, you will be responsible for coordinating stability studies for regulatory submissions (NDA, ANDA, 510(k)) according to industry guidelines to support product storage conditions and expiration-dating periods.

RESPONSIBILITIES:
' Generate stability protocols and commitments to meet regulatory guidelines, and implement change control when revised.
' Initiate study starts according to approved protocols and regulatory commitments.
' Enter new lots into the stability software and applicable tracking systems.
' Pull samples at appropriate time points and deliver to the Analytical and Microbiology Labs, as appropriate.
' Update the stability observation database as new observations are started, and monitor the forms to ensure they are complete and necessary corrective action implemented.
' Update the stability variance database and ensure that variances are implemented and documented.
' Perform the final review of stability data to ensure accuracy and determine if modifications to studies are required.
' Maintain stability documents to ensure that they are cross-referenced and can be quickly retrieved.
' Write and audit stability reports for regulatory submissions (510(k), NDA, ANDA) or marketing partners.
' Respond to regulatory deficiencies as necessary.
' Attend team meetings as necessary.
' Write or revise SOP's as required.
' Perform burst testing on stability samples.
' Monitor the Temperature Monitoring System (TMS) data for the stability chambers, and follow up on any necessary corrective action.

REQUIREMENTS:
Bachelor's degree in scientific discipline, preferably in math or science combined with two to five years of relevant experience in the pharmaceutical or medical device industry.
Knowledge of cGMP's and ISO9001 with a commitment to following written procedures.
Experience in a Quality or Stability role is highly desirable.
Ability to work independently with minimal supervision to meet deadlines.
Organized, excellent attention to detail and able to maintain a high degree of accuracy.
Excellent oral and written communication skills with the ability to write standard operating procedures.
Excellent interpersonal skills with the ability to work well with employees at all levels in the organization.
Ability to accurately audit and review data and write reports.
Computer literacy in Excel, Word and Access programs.
Experience with Stability System II Software a plus.

Position is a Direct Hire opportunity thru Kelly Scientific Resources. Hours are first shift (8 AM to 5 PM), Monday to Friday. Pay range is $37-45K based upon experience.

If interested please apply online or call Nan Milausnic at 303-427-4140.

Kelly Scientific Resources is the world leader in the scientific staffing industry. Our recruiters are scientists themselves, with degrees in chemistry, biochemistry or biology with a minimum of five years prior industry experience. We provide scientific staffing services on a temporary, temp to hire, and direct placement basis to a broad spectrum of industries including Pharmaceutical, Biotechnology, Chemical, Environmental, and Food Science.Kelly Services is an Equal Opportunity EmployerContact?Information?:.Sheridan Park 2
Westminster?CO?80031