Employment Opportunities at Epic

May 17, 2017

QUALITY CONTROL CHEMIST

 

Several positions are available in the Quality Control Lab.  Candidates must have a Bachelor’s Degree in Chemistry, or a related science field.

 

One to three years of laboratory experience is preferred, ideally in a pharmaceutical environment with solid dosage forms. 

 

Essential Duties & Responsibilities:

 

Thorough understanding of cGMPs, specifically as they apply to a Pharmaceutical environment.

 

Experience testing raw materials (API/Excipients), in-process, finished product and stability samples

 

Release/Testing of Purified Water in Manufacturing.

 

Need to understand & follow USP & In-house testing methods.

 

Need basic knowledge of wet chemistry techniques and pharmaceutical lab instrumentation including HPLC, UV/Vis, FTIR, IR, Dissolution Apparatus, Karl Fischer titration, and others. 

 

Must be able to work effectively in a team in a quality oriented laboratory environment to meet company objectives and commitments.

 

Must have strong written and verbal communication skills and a good command of the English language.

 

Must demonstrate good safety practices at all times, including appropriate use of protective equipment.

 

Must be able to complete assigned work in a timely manner, follow instructions. Fast learner!

 

Physical Demands/Environmental Conditions:  Some light lifting, some reaching, bending, standing for short periods of time. 

 

 

Epic Pharma is an equal opportunity employer and offers a competitive starting salary and benefits package, including medical/dental/vision and 401k.

 

 

Only resumes/cover letters with Salary History and Salary Requirements will be considered!

 

All candidates must be authorized to work legally in the United States on a full-time basis for ANY EMPLOYER.

 

 

May 17, 2017

SENIOR REGULATORY AFFAIRS ASSOCIATE

 

Position Summary: 

The Senior Regulatory Affairs Associate will review and prepare regulatory documents related to ANDA submissions.  Prepare submissions for projects/products covering product development, registration, approval and post approval activities for ANDAs/NDAs.  This individual will be part of project teams, and provide Regulatory insight and direction.  Review and compile Regulatory submissions.  Must have excellent written and effective verbal communication skills, be proficient in project management, and be a flexible individual able to work in a fast paced environment.

 

This is an Exempt, Salaried position.

 

Minimum Requirements:

BS in Pharmacy, Chemistry or related discipline

2 – 3 years experience in pharmaceutical regulatory affairs.

Experience in Generic Regulatory filings preferred.

 

 

MAJOR DUTIES/RESPONSIBILITES

 

Author and compile Regulatory filings including new ANDA/NDA submissions, amendments, supplements, annual reports, safety reports.

 

Review all source documentation for scientific and regulatory requirements.

 

Review and communicate emerging regulatory requirements to ensure compliance.

 

Act as liaison between Regulatory Affairs and other functional areas

 

Represent Regulatory Affairs in cross functional meetings.

 

Interface with external regulatory groups and regulatory agencies.

 

Other daily, weekly, monthly etc., reports, tasks, projects as required in the Regulatory Affairs Department.

 

Send resumes to:

                       Epic Pharma, 227-15 N. Conduit Avenue, Laurelton, NY 11413

                       Email: hr@epic-pharma.com

 

 

Epic Pharma is an equal opportunity employer and offers a competitive starting salary and benefits package including medical/dental/vision/401k.

 

 

Contact Us: Phone:718.276.8600 Fax: 718.949.3120   Customer Service: 1.888.EPIC.RX1