Stability Associate Position Available In Palm Beach, Florida

Job Description:

Job DetailsLevel ExperiencedJob Location ADMA Biologics FL -Boca Raton, FLPosition Type Full TimeEducation Level 4 YearDegreeJob Category ManufacturingDescription ADMA Biologics is abiopharmaceutical company relentlessly committed to creatingsuperior products for immunodeficient patients at risk forinfection. It is our devotion to this underserved population thatfuels us and our hands-on approach to production and developmentthat sets us apart. If you are looking for a dynamic, innovative,growing company in the biopharmaceutical industry that is committedto excellence and integrity, then consider ADMA Biologics. Wecurrently have an exciting opportunity available for a StabilityAssociate in Boca Raton, Florida! The Stability Associate isresponsible for executing stability studies of plasma-derivedbiopharmaceutical products in a cGMP environment. Areas of focusare planning and executing studies, managing study inventory, andscheduling and performing stability pulls. Additional stabilityrelated support activities include writing protocols, monitoringand trending data, and writing stability reports.

QualificationsKey Responsibilities:

Responsible for all day-to-day activities ofthe Quality Control Stability program: Plans and executes stabilitystudies. Manages stability inventories. Schedules and performsstability pulls. Monitors the completion of test data. Performsdata verification for stability reports. Supports the management oftemperature-controlled chambers. Supports and assists in all otheraspects of the Quality Control Stability program as needed:

Preparation and revision of technical documentation for departmentareas of responsibility such as Procedures, Stability Protocols,Specifications, etc. Perform and interpret statistical analysis oftrends by linear regression, ANCOVA, and control charting usingappropriate data analysis software. Preparation and revision ofstability data reports with adherence to regulatory and companyguidelines. Preparation of thorough change controls andinvestigations for quality systems. Possesses expertise and guidesothers in cGMP and cGDP practices in documentation and execution ofjob functions. Ensures compliance with all regulatory requirementsby verifying procedures are being followed, all recordkeeping iscurrent, proper maintenance occurs, and new requirements areidentified as they arise. Effectively communicates criticalstability and quality related information to appropriate teams. Isa subject matter expert for areas of responsibility for internaland external customers and participates in internal and externalaudits. Identifies opportunities for and participates in continuousimprovements to increase efficiency and compliance. Performs,reviews, and trains on processes performed within the QCdepartment. Is technically proficient in Microsoft Office (JMPsoftware a plus). Assists in other QC, regulatory support, and dataanalysis functions, as assigned by the Manager. Frequent internalcontact with various departments and individuals of all levels.

Some external contact with vendors may be required. Analyzes issuesand exercises judgment within defined procedures to determineappropriate resolution to problems. Reports on non-standardproblems with area management. Prioritizes work with the directionof the manager. Is familiar with Standard Operating Procedures(SOP) writing procedures.

Education Requirements:

A bachelor’s ormaster’s degree in Biology, Chemistry, Mathematics, or a relatedscientific field is required.

Experience Requirements:

Requires atleast 1 – 3 years of experience in a regulated laboratory setting,and previous work experience in a regulated environment (FDA, EPA,etc.). Must be familiar with GLP and GMP guidelines. Must haveworking knowledge of trending and/or stability analysis in aregulated environment. In addition to competitive compensation, weoffer a comprehensive benefits package including: 401K plan withemployer match and immediate vesting Medical, Vision, Life andDental Insurance Pet Insurance Company paid STD and LTD CompanyPaid Holidays 3 Weeks’ Paid Time Off (within the first year)Tuition Assistance (after the first year) Easily accessible toTri-Rail Free shuttle to the Boca Tri-Rail station ADMA Biologicsuses E-Verify to confirm the employment eligibility of all newlyhired employees. To learn more about E-Verify, including yourrights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.