Careers

Project Coordinator

Overview

This position in a generic pharmaceutical company facilitates efficient and focused project team planning and coordination to achieve the company’s objectives. The position will play a key role maintaining coordination and communication between internal departments, and between the company and its outside partners.

Responsibilities

  • Work within technical teams to help development and maintain timelines, track deliverables with guidance from management.
  • Work with technical teams to understand the fundamentals of product development and gain knowledge.
  • Facilitate technical teams by handling logistics along the product development processes.
  • Set-up and attend internal and external technical meetings.
  • Understand the fundamental concepts of project timelines to reach key milestone dates for success. Work with senior staff to understand how to provide updates on progress against project objectives, milestones, timelines and metrics.
  • Establish and maintain effective communication and collaboration with functional area peers, working proactively to ensure team unity.
  • Monitor and work effectively during day-to-day interactions with technical teams.

Qualifications

  • B.S., or M.S. in a scientific discipline with 1 – 3 year experience.
  • Good analytical, organizational, interpersonal and written skills.
  • Is thorough when performing work, conscientious and attentive to detail and with good communication skills.
  • Proficient in MS Office (Word, Excel, Project, PowerPoint, Outlook), and Adobe Pro.

Quality Assurance/Record Audit Position

Overview

QA opportunity is available at Salus Pharma LLC. In Salus Pharma LLC, we develop and manufacture Solid Oral Dose tablets and capsules. We are seeking an experienced QA associate on a permanent basis. Considering: local candidates with GMP experience, in a manufacturing setting, within a QA department.

Responsibilities

  • Assists project teams in the multiple functional areas throughout the company in completing controlled documents in a timely manner to meet project deadlines.
  • Author, review, and approve cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.
  • Review GMP QC laboratory records, notebooks and documents to ensure compliance with internal procedures, GMP, and other regulatory requirements.
  • Facilitates the coordination of the Investigation/Deviation/ CAPA system and training.
  • Provides support for during inspections by assisting with request processing, tracking, and other support activities.
  • Scan documents for electronic archival.
  • Facilitate and track document reviews and approvals of validation documents.
  • Assist with metric generation, tracking and performance improvement of Quality Systems (change controls, deviations, CAPAs, etc.)
  • Assist with the creation of SOPS in support of GMP systems or processes.

Qualifications

  • Bachelor’s degree in science or equivalent is required; Biology/Chemistry preferred.
  • 3 year of prior work experience in a Biotechnological, Pharmaceutical, or Clinical environment is required; prior GxP experience/training is a plus.
  • Excellent written and verbal communication skills required, including Responsible Business Communication; scientific writing experience is preferred.
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Must be proficient with MS Office applications.

ARD / QC Chemist

Overview

The ARD/QC Chemist supports, development and validation of methods analytical test methods, evaluation and testing of raw materials, and testing of non-commercial materials to support product development. The department provides analytical services to manufacturing, Technical Services, Validation and raw material qualification. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements.

Basic Function

  • Analyze data, document results, maintain laboratory notebook according to cGMP and internal guidelines. Communicate results in written and oral presentations.
  • Contribute to continuous improvement within the group
  • Comply with FDA, performing all work in a safe manner. Maintain proper records in accordance with all SOP’s and policies.

Responsibilities

  • Analysis of finished products, in-process materials, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
  • Preparation of reagents/standards/media needed for analysis according to established methods.
  • Disposal of hazardous waste according to environmental regulations and company/departmental procedures.
  • Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks.
  • Assures right-first-time execution of departmental methods and SOPs.
  • Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
  • Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical document.
  • Provides support for ordering and maintaining inventory of laboratory materials and equipment.
  • Performs other miscellaneous duties as required.
  • Works flexible hours including weekends and evenings to accommodate the production / validation schedule.

 Qualifications

  • Minimum Bachelor’s degree from four-year college or university in any of the following disciplines: Chemistry, Biology, Microbiology, or related sciences (as applicable).
  • Minimum of 1 year relevant pharmaceutical laboratory/analytical experience
  • Experience with common pharmaceutical laboratory equipment including, but not limited to:
    • UV spectroscopy
    • HPLC and GC instrumentation
    • Dissolution testing
  • Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions.
  • Knowledge of the following:
    • Safety and hazardous waste requirements
    • cGMP & cGLP standards

For confidential consideration please send resume to:

hiring@saluspharmallc.com

 

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