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 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 systems & operations, 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).
- Provide insight, leverage experience and knowledge, to drive process innovations that enhance efficiency and compliance.
- Action organizational tasks including oversight and escalation of open tasks and timelines, document management, tracking of tasks, and generation of technical reports.
- 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.
- To be receptive to escalation of minor 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.
- Identify, create, and implement training, as needed, to address changes to process, procedure or changes in regulations/requirements.
- QA review and approval 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 services to ensure compliance with company and regulatory requirements.
- 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)
- No less than three (3) 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 the floor as Quality Assurance 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).All job requirements in the job description provided indicate the level of knowledge, skills, and/or abilities deemed necessary to perform the job competently.
Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation.
25 To 30 (USD) Hourly
