QA Associate I, Document Control

3 weeks ago

Maryland Line, United States Pharmaceutics International Inc Full time
Job Overview:

The QA Associate ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing a role in any of the functions: Quality Operations, Process Quality, Batch Release, or Quality Systems in accordance with cGMP and related company SOPs, state, federal and local laws, as applicable.

Responsibilities:
  • To complete quality-related tasks as directed by the supervisor associated with the review of operations performed within the functional area. These may include one or several of the following quality operational tasks, product release, process quality, document control, quality systems or operations, or compliance.
  • To support or contribute to the preparation, review, and approval of GMP-related documentation in accordance with approved SOPs and applicable regulations (i.e., GMPs, GDPs).
  • To perform or assist in general organizational tasks including oversight and escalation of open tasks and timelines, document management, tracking of tasks, generation of technical reports, and reporting of quality metrics.
  • To ensure that appropriate quality standards are applied in accordance with regulatory, pharmacopeias, and company requirements to ensure compliance.
  • To assist in quality-related activities that may include the preparation and review of GMP documentation, and the management of paper and electronic records in adherence to document management and retention procedures.
  • To escalate compliance issues appropriately and timely, when discovered.
  • To complete assigned training in a timely fashion to ensure that both personal and department training status remains current.
  • QA review of data to ensure conformance to specifications or requirements to maintain quality assurance objectives to meet regulatory requirements.
  • Work collaboratively with various stakeholders in the review, issuance, or providing service to ensure compliance with company and regulatory requirements.
  • Perform other duties as assigned.
Qualifications:
  • Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
  • Prefer one (1) year of Quality Assurance experience in a GMP-regulated industry, such as pharmaceutical, biologics, medical devices, dietary supplements, food, cosmetics, or in combination with relevant education.
  • Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
  • Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
  • Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
  • Must be able to comprehend and follow all applicable SOPs.
  • Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
  • Able to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
  • Good understanding of cGMPs, industry, and regulatory standards and guidelines.
  • Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
  • Demonstrate the ability to portray the appropriate level of integrity and professionalism.
  • Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
  • Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
  • Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
  • Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
  • Results-oriented and efficient.
  • Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
  • Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
  • Demonstrate the ability to work well in a cross-functional team environment.
  • Must communicate fluently in English and have legible handwriting.
Physical Demands:
  • Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
  • Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
  • Ability to lift up to 40 pounds on occasion.
  • Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

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