Job Summary:
The QA Associate ensures compliance with CGMP and internal policies, procedures, and specifications. This position is responsible for performing a role in any one or more of the following functions: Quality Operations, Process Quality, Batch Release, Quality Management Systems, and Compliance in accordance with CGMP and related company SOPs, state, federal and local laws as applicable.
Duties/Responsibilities:
- To compliantly and consistently complete quality related tasks directed by the supervisor associated with the review of operations performed within the site. These may include one or several of the following quality operational tasks, product release, process quality, document control, quality management systems, and compliance.
- To contribute to the preparation, review, and approval of GMP-related documentation in accordance with approved SOPs and applicable regulations (i.e., GMPs, GDocPs).
- Action organizational tasks including oversight and escalation of open tasks and timelines, document management, tracking of tasks, and generation of technical reports, specifically to the Quality Management Systems
- Exemplify the appropriate quality standards are applied in accordance with regulatory, pharmacopeias, and company requirements to ensure compliance.
- With minimal supervision, execute quality-related activities that may include the preparation and review of GMP documentation, the management of paper and electronic records in adherence to document management and retention procedures.
- Manage client communications regarding Quality Management Systems items, such as Change Controls, Deviations, Out-of-Specifications, Hypothesis Test Plans, CAPAs, Complaints, and other metrics related to Quality Management Systems.
- Other duties as assigned.
Required Skills/Abilities:
- Familiarity with Microsoft programs, such as Word, Excel, PowerPoint, Access, Project, etc.
- Knowledge / Experience with electronic Quality Management Systems such as MasterControl or TrackWise
- Knowledge of current federal, local, and international regulations regarding the production, testing and release of drug substances and products.
- Excellent oral and written communication skills
- Ability to manage multiple priorities and re-prioritize tasks as required
- Excellent problem-solving and organizational skills
Education and Experience:
- Bachelor's degree or higher degree preferred, or equivalent experience in the pharmaceutical industry)
- Preferred 1-2 years 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.
- Preferred experience with working on with aseptically filled products.
Physical Requirements:
• 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 (lbs.) pounds, on occasion.• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
25.00 To 30.00 (USD) Annually
