QA Associate, QMS
Actalent
Job Title: QA AssociateJob Description
The QA Associate ensures compliance with CGMP and internal policies, procedures, and specifications. This position is responsible for performing roles in Quality Operations, Process Quality, Batch Release, Quality Management Systems, and Compliance in accordance with CGMP and related company SOPs, as well as state, federal, and local laws.
Responsibilities
+ Compliantly and consistently complete quality-related tasks directed by the supervisor associated with reviewing operations performed within the site. These may include quality operational tasks, product release, process quality, document control, quality management systems, and compliance.
+ Contribute to the preparation, review, and approval of GMP-related documentation in accordance with approved SOPs and applicable regulations.
+ Action organizational tasks including oversight and escalation of open tasks and timelines, document management, tracking of tasks, and generation of technical reports, specifically related to the Quality Management Systems.
+ Ensure appropriate quality standards are applied in accordance with regulatory, industry, and company requirements to ensure compliance.
+ Execute quality-related activities with minimal supervision, including preparation and review of GMP documentation, and 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.
+ Perform other duties as assigned.
Essential Skills
+ Proficiency in quality assurance, batch records, QMS, and compliance.
+ Experience in pharmaceutical environments and batch record review.
+ Familiarity with Microsoft programs, such as Word, Excel, PowerPoint, Access, and Project.
+ 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.
+ Strong problem-solving and organizational skills.
Additional Skills & Qualifications
+ Bachelor’s degree, or an equivalent combination of education, training, and professional experience that provides the required knowledge, skills, and abilities.
Work Environment
The QA Associate will primarily work with the QA Compliance team but will engage with different departments as needed.
Job Type & Location
This is a Contract position based out of HUNT VALLEY, Maryland.
Pay and Benefits
The pay range for this position is $25.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in HUNT VALLEY,MD.
Application Deadline
This position is anticipated to close on Sep 9, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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