Quality Assurance Specialist

Excite Pharma Services is a contract research organization (CRO) & contract manufacturing organization (CMO) providing analytical & manufacturing services to pharmaceutical clients in support of new drug development and technical transfer of existing pharmaceuticals both human and animal.

Primary Responsibilities:

To support the Company’s Quality Assurance and compliance programs by initiating & reviewing documentation, maintaining compliance systems, and performing inspections of GMP facilities, and knowledge of CFR and/or FDA guidance.

Reports to:

VP of Quality

Manages others:

No

Specific responsibilities:

• Reviewing GMP documentation, line clearances, status control of Raw Materials and Finish Product, participate in internal audits; keeping the information well organized and in a state of inspectional readiness; maintaining record integrity and security; and retrieving and auditing on-site record documentation.
• Assist in maintaining the Quality Assurance compliance systems in accordance with U.S. Regulations and internal standards.
• Perform review of documents related to GMP and/or GLP and/or GCP activities.
• When appropriate, assist in FDA inspections regarding regulated activities.
• When appropriate, assist in internal audit procedures.
• Assist in the preparation, report, and follow-up of internal and external audits.
• Support senior staff members in their responsibilities and tasks; assist in month-end reports, tracking and trending.
• Revise existing SOPs for the QA department as needed.
• Stay current with CFR and/or FDA guidance documents.

Background:

• Bachelor's degree in Chemistry or Equivalent Experience Preferred.
• 3 years of Experience (GMP Environment)
• Good interpersonal, communication and negotiating skills with the ability to effectively present information and respond to questions from individuals and/or groups both within the organization or while representing the organization to clients.
• Maintain thorough understanding of scientific instrumentation and/or manufacturing techniques.
• Excellent knowledge in Microsoft Office Suite (MS Word, Excel, Power Point, etc.) and other office applications

Skills:

• Knowledge of cGMPs and/or GCPs and/or GLPs and their application to a wide variety of problems and situations.
• Excellent communication and technical writing skills in the English language.
• Ability to work independently, as well as ability to function as a team player, ability to accept personal accountability for successful job performance, and ability to initiate and offer suggestions aimed at improving service to our customers.
• Ability to work efficiently and accurately to meet set goals and timelines, and attentive to detail.
• Ability to work in a fast paced and flexible work environment where priorities can change.
• Familiar with pharmaceutical equipment, utilities, and validation concepts.
• Good interpersonal and communication skills in English language (writing, speaking, comprehension)
• Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Nitro PDF

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Work setting:

• In-person