Stability Supervisor
Atrium Staffing - Eatontown, NJ

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ID:
DDP/WSS

Type:
Temporary

Practice Area:
Scientific

Compensation:
Open DOE

Location:
New Jersey

Education:
Bachelor's Degree

City/Region:
Eatontown

Status:
Full Time

We have an opportunity at a top generic prescription medication provider located in Eatontown, NJ. The growing company is looking to hire a Stability Supervisor on a temporary basis. The Stability Supervisor position will last approximately 3-6 months.

Responsibilities:
Supervises the Retain/Stability Group’s day to day activities. Responsible for administration of the retain/ stability program. Plans and controls procedures related to obtain/inspect/store retain and stability samples, initiating stability studies. Implements strategies to generate, evaluate and submit marketed products’ stability data for the annual product reviews and for FDA. Responsible for monograph/stability protocol reviews and approvals, laboratory or manufacturing investigations regarding product stability or product storage issues

Administers the retain sample program to assure timely and proper inspection and storage of samples. Secures control of use of retain samples, evaluates all retain sample data

Determines the schedule of stability samples. Coordinate testing to assure testing schedule is met. Assures proper samples are taken and are stored under required conditions. Evaluates data

Prepares and/or approves reports, investigations, and other regulatory and upper management communications as required for stability and retain sample issues. Assures deviations are reported to management immediately

Reviews and approves stability protocols for monograph revisions, and for Technical Services stability evaluation projects. Reviews and approves Technical Services stability general reports, and change controls with stability issues

Manages system to generate and trend stability data of commercial products and special stability studies

Issues reports in a timely manner for Annual Product Reviews and Annual Stability Commitments to FDA

Assures that regulatory commitments, cGMPs, Specification and Test (SAT) methods, and SOPs related to stability and retain samples are followed

Acts as a designee for Assoc. Dir., QA Compliance

Develops direct reports, supports the department budget

Qualifications:
Strong supervisory skills required to lead and develop direct reports

Good organizational skills, knowledge of cGMPs, and regulatory requirements is necessary

Verbal and written communication skills, interpersonal and negotiation skills in resolution of conflicts are essential

Working knowledge of computer functions with proficiency in Microsoft Word and Excel is required

Education Requirements:
Minimum BS degree in Pharmaceutical Science, Chemistry or related science is required

Previous Quality Assurance and 3-5 years of supervisory experience is necessary

About this company
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Founded in 1995, Atrium Staffing is a privately held, woman-owned staffing and recruitment firm with revenues grossing over $185M. Atrium...