Quality Associate

Job Description

Quality Assistant (FULL TIME)

Company Description:

Darmerica is a licensed distributor of high quality bulk pharmaceutical ingredients. We supply a full line of active pharmaceutical ingredients (APIs) excipients, nutraceuticals, cosmetic ingredients, bio-chemicals as well as specialty & fine chemicals.

We are currently looking for a highly motivated Quality Associate with a willingness to learn and grow within the company. The candidate must be familiar with FDA regulations on bulk APIs for the pharmaceutical and compounding pharmacy industry.

Primary Responsibilities:

·· Oversee the operations of Quality Unit including product releases of all incoming materials, relabeled/repackaged products for storage and shipping of products

· Prepare and approve all SOPs prior to implementation

· Review/Analyze Assay/Potency HPLC test results on bulk APIs and qualify the suppliers according to FDA regulations on bulk APIs

· Maintain the change control, deviations systems, training program, Investigations and tracking of CAPA

· Conduct internal audits, risk assessments and annual quality reviews and prepare applicable reports, including recalls (if any).

· Oversee the calibration program of equipment.

· Ensure that adequate environmental temperature monitoring is in place in cGMP facilities.

· Keep the management informed of any significant risks and non-conformities.

· Host inspections by FDA, Board of Pharmacies and customers.

· Review and maintain completed batch records.

· Assist operations with daily activities.

· Other duties as assigned (after training)

Qualifications:

· · Applicants must be a US citizen or with green card

· University Graduate in Science such as Chemistry, Biochemistry or Pharmacy (Master Degree is an asset)

· Minimum of 3-year hands on experience in HPLC Assay/Potency testing and data analysis at Quality Control Lab in the Pharmaceutical/Compounding Pharmacy Industry or similar industry (4 -5 year experience is preferred )

· Knowledge of FDA regulations on bulk APIs for the Pharmaceutical Industry or Compounding Pharmacy Industry

· Proficient with MS Word and Excel, and strong keyboarding skills

· Exceptional interpersonal skills, excellent verbal and written communication skills

· Able to work effectively and independently in a team environment

· Strong time management and prioritization skills with ability to multi-task and detail oriented

Leadership skill is an asset

Education: Bachelor’s Degree in Sciences a minimum (Chemistry, Pharmacy, Health Sciences, Biology, etc.)

Salary Range: $45,000 - $55,000 per year based on experience, salary can be adjusted after probation based on performance. Employee bonus plan up to 10% annual performance bonus, prorated quarterly after completing probation.

Full Time Working Hours: 35 hours weekly, 9am to 5pm, Monday to Friday

Location: Ft Lauderdale (Davie), Florida

**All new hires are subject to a Background Check/Screening**

Please email your resume with subject line Quality Assistant (Full - Time) to: hr@Darmerica.com

Job Type: Full-time

Pay: $45,000.00 - $55,000.00 per year

Benefits:

• Paid time off

Schedule:

• Monday to Friday

Work Location: In person

Salary : $45,000 - $55,000