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Job Title: QA Associate I, Document ControlJob Description

The QA Associate I, Document Control ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing roles in 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

+ Complete quality-related tasks as directed by the supervisor associated with the review of operations performed within the functional area. These may include quality operational tasks, product release, process quality, document control, quality systems or operations, or compliance.

+ 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).

+ 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.

+ Ensure that appropriate quality standards are applied in accordance with regulatory, industry, and company requirements to ensure compliance.

+ 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.

+ Escalate compliance issues appropriately and timely, when discovered.

+ 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.

Essential Skills

+ Document control

+ Quality assurance

+ Batch records

+ Audit

+ Compliance

+ Pharmaceutical

+ Quality system

+ Batch record review

+ GMP

Additional Skills & Qualifications

+ Bachelor’s degree, or an equivalent combination of education, training, and professional experience that provides the required knowledge, skills, and abilities.

+ Preferably one (1) year of Quality Assurance experience in a GMP-regulated industry such as pharmaceutical, biologics, medical devices, dietary supplements, food, or cosmetics.

+ Ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

+ Technical knowledge necessary to make sound decisions on development issues with minimal supervision.

+ Ability to analyze data and information and assess and resolve complex problems/issues as required.

+ Comprehension and adherence to all applicable SOPs.

+ Knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.

+ Understanding of 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.

+ Familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

+ Integrity and professionalism in conduct.

+ Effective communication skills with management, staff, regulators, and client representatives in written and verbal formats.

+ Ability to complete tasks accurately and according to established and shifting timelines.

+ Ability to make quality scheduling, resource allocation, and priorities decisions.

+ Energetic, execution-focused, self-motivated, and organized individual accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

Work Environment

Will be working in different departments but mostly with the QA Compliance team.

Pay and Benefits

The pay range for this position is $20.00 - $25.00/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 May 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 [email protected] (%[email protected]) for other accommodation options.