Job Description

Job Title: Document Control SpecialistJob Description We are seeking a diligent and detail-oriented Document Control Specialist to facilitate the change control process from initiation through all workflow steps to implementation. You will review completed change orders for content and approvals, ensuring compliance with ISO, FDA, and internal requirements. You will be responsible for managing all documentation related to manufacturing, quality control, quality assurance, and distribution of pharmaceutical products, including the development and maintenance of document control systems. Responsibilities Facilitate the change control process from initiation to implementation, including reviewing completed change orders for content and approvals. Review change orders and items for completeness and compliance with ISO, FDA, and internal template and procedure requirements in a timely manner. Select and/or verify required approvers of changes per procedures. Manage and maintain all documentation related to manufacturing, quality control, quality assurance, and distribution of pharmaceutical products, including batch records, standard operating procedures, specifications, and other critical documents. Develop and maintain document control systems to ensure the accuracy, completeness, and accessibility of all documentation. Use the electronic Quality Management System for controlled documentation approval, revision, and obsoletion. Ensure compliance with all regulatory requirements, including FDA, cGMP, and other industry standards. Review documents for format, accuracy, and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts. Complete required documentation accurately and in a timely manner following Good Documentation Practices (GDP). Support the Training Program by entering training data and monitoring completion. Manage and maintain the training matrix and job-by-function report. Essential Skills Experience in document control and quality standards. Knowledge of ISO and FDA regulatory requirements. Strong attention to detail and organizational skills. Ability to manage both electronic and physical records. Proficiency in using electronic Quality Management Systems. Good Documentation Practices (GDP) knowledge. Additional Skills & Qualifications Associate's degree or high school diploma required. Experience with Greenlight Guru is a plus. Familiarity with mechanical drawings and inspection processes. Knowledge of Quality Management Systems (QMS). Work Environment This role is based in an onsite environment, operating on the 6th and 8th floors of a collaborative setting. Employees frequently travel between the R&D team and Quality team, fostering a highly interactive and collaborative work environment. The company operates in two locations in Kendall, with one location in a high-rise building housing the Quality team, and the other in a two-story building with a surgery center on the first floor and the design team on the second floor. Pay and Benefits The pay range for this position is $20.00 - $27.00 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 Miami,FL. Application Deadline This position will be accepting applications until Dec 13, 2024. 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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