GMP Specialist

  • Somerset St, Franklin Township, NJ, USA
  • Full-time

Company Description

AthenPollo is a fast growing and dynamic organization providing IT consulting and staffing services for over 8 years and committed to becoming one of the nation’s premier IT companies.  Our highly skilled and experienced team strives to deliver the highest levels of service and value to our Customers and Consultants. Our client base is comprised primarily of Fortune 500 companies and large systems integrators.

Job Description

AthenPollo is looking for a GMP Specialist to support a leading Pharmaceutical client. This is a Full Time position based in Somerset, NJ. Security, Satisfaction, flexible working hours and Happiness, come along with a handsome package!

 

Job Title: GMP Specialist.

Job Type: Full time permanent.

Location: Somerset, NJ.

Full-Time Benefits: Full.

 

Candidate Details:

·         5+ to 7 years experience.

·         Seniority Level – Associate.

·         Management Experience Required – No.

Minimum Education: Bachelor's Degree.

Job Description:

Essential functions:

·         Include the following. Other duties may be assigned.

·         Leadership role in site compliance Operations meetings.

·         Conducts GMP training with materials approved by Quality.

·         Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, contract customers, internal audits, etc.

·         Room checklist and logbook program oversight in accordance with approved SOP’s.

·         Leadership for and conducting of daily walk-throughs for GMP potential concerns; and subsequent reporting and tracking to closure.

·         Assures area management is accountable for compliance at all times with direct, independent reporting relationship to site head.

·         Follow up and support investigations assigned to site Operations.

·         Jointly responsible for CAPA development with area HODs and implementation of action plans along with tracking of KPIs.

·         Special assignments from site head relating to GMP compliance.

·         Conduct weekly facility walk through evaluations with facility maintenance.

·         Review employee practices for proper aseptic techniques, including media fill videos.

·         Provide daily oversight to Production Supervisors and Team Leads of all documentation within the formulation, filling and packaging departments. This is to assure effective detection and real-time corrective action of operator errors.

·         Conduct aseptic behavior training in concert with Quality.

·         Assist in media fill program and observer role.

·         Standing member of site Technical Review Board.

Additional Responsibilities:

·         Special projects assigned.

Qualifications:

·         To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.

Education & Experience:

·         Bachelor Degree in Scientific Discipline or equivalent combination of education and experience.

·         5 years minimum work experience in Aseptic Manufacturing for a FDA regulated and approved facility.

·         Excellent oral and written communication skills.

Job Prerequisites:

·         Hands on experience required to manage and trouble shoot major projects.

·         Have a thorough knowledge in applicable FDA/cGMP and ICH guidelines.

·         Skilled in presentation to and interface with senior level management.

 

Contact: Syed Irfan

Cell: 616-855-1605

Email : Syed.Irfan(AT)athenpollo.com

Qualifications

FDA.GMP

Additional Information

All your information will be kept confidential according to EEO guidelines.