Document Control Associate

Job Title QA Specialist II / Document Control Associate Job Description The QA Specialist II / Document Control Associate ensures that production processes remain client-focused, results-oriented, performance-driven, and fully compliant with applicable internal and external requirements. This role compiles batch record review records and batch disposition documentation to support Good Manufacturing Practice (GMP) operations and plays a key part in the manufacture and release of cell banks, bulk drug substances, plasmid products, and final drug products intended for human use. Responsibilities Provide quality assurance oversight and support to GMP manufacturing projects, working closely with QA Management to ensure effective QA coverage for the manufacture of master and working cell banks, bulk drug substance, plasmid products, and final drug product. Support Manufacturing and Quality Control departments in performing and documenting deviations and failure investigations, including conducting root cause analysis, assessing product and facility impact, and identifying and implementing effective corrective and preventive actions (CAPAs). Track and evaluate non-conformances that occur during drug product manufacturing and review change controls to determine their impact on assigned projects. Perform audits and walkthroughs of manufacturing and support areas, including in-process batch record review, to verify adherence to internal procedures, GMP expectations, and industry best practices. Review executed batch production records and associated supporting documentation such as logbooks, quality control test reports, environmental monitoring reports, and cleaning records for completeness and compliance. Compile and organize batch disposition documentation in a timely manner to support the final disposition and release of finished products. Perform QA on-the-floor activities in support of client projects, including line clearance and room release, observing critical processes, reviewing documentation in real time, and resolving issues that arise during manufacturing. Support the review and disposition of raw materials in accordance with approved internal procedures. Receive and issue Batch Production Records and labels to manufacturing departments, verifying accuracy and completeness based on QA Document Control requirements. Ensure Standard Operating Procedures (SOPs) remain current and effective, and verify through direct observation that staff perform routine tasks in accordance with approved SOPs. Review quality control test reports related to batch processing to confirm compliance with specifications and documentation standards. Train Level 1 QA Specialists as required, providing guidance on QA processes, documentation practices, and GMP expectations. Drive a culture of continuous improvement and operational excellence by promoting self-detecting and self-correcting processes and systems and fostering strong ownership and accountability within the team. Actively participate in recruiting efforts to help secure, onboard, and develop new staff members within the QA function. Work evening and weekend hours as needed to support production operations and ensure timely QA support and batch disposition. Perform additional duties as assigned to support overall quality assurance and document control activities. Essential Skills Minimum 5 years of GMP-related experience in the biopharmaceutical, pharmaceutical, or related industry. Demonstrated experience with batch record review and preparation of batch disposition documentation in a GMP environment. Hands‑on experience supporting deviations, failure investigations, root cause analysis, and CAPA implementation. Working knowledge of FDA, EMA, and ICH regulations and guidelines and their practical implementation in GMP operations. Proficiency with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements. Experience in quality assurance activities, including audits, QA on‑the‑floor support, and document control. Ability to define problems, collect and analyze data, and draw valid conclusions to support investigations and decision‑making. Strong organizational skills with the ability to prioritize and manage complex processes and projects in a fast‑paced environment. Strong verbal and written communication skills for clear documentation, reporting, and cross‑functional collaboration. Exceptional interpersonal skills with the ability to influence behaviors, negotiate, and resolve challenges with poise, tact, and diplomacy. Ability to follow instructions and Standard Operating Procedures accurately and consistently. Proficiency with Microsoft Suite, including Word, Excel, Access, Visio, and PowerPoint. High attention to detail, with a track record of being organized, responsible, and thorough in documentation and review activities. Additional Skills & Qualifications BS/BA in life sciences or a related field. Previous experience with TrackWise Digital and Pilgrim quality systems is a plus. Experience in document control within a GMP environment. Experience performing or supporting internal audits, walkthroughs, and in‑process batch record reviews. Ability to organize and disseminate information efficiently to multiple stakeholders. Capability to multi‑task effectively while maintaining accuracy and compliance. Demonstrated creativity in problem‑solving and process improvement. Familiarity with electronic quality management systems and digital documentation tools is beneficial. Work Environment This role operates within a GMP‑compliant facility, with work primarily performed in an office or desk‑based setting that supports manufacturing and quality operations. The position requires frequent interaction with manufacturing and support areas, including time spent on the production floor to conduct QA on‑the‑floor activities, audits, and in‑process reviews. The environment is fast‑paced and highly regulated, with a strong focus on documentation accuracy, regulatory compliance, and cross‑functional collaboration. Evening and weekend work may be required to support production schedules and ensure timely QA oversight and batch disposition. Job Type & Location This is a Contract position based out of Rockville, MD. Pay And Benefits The pay range for this position is $25.77 - $25.77/hr. Requirements 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: 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 Rockville, MD. Application Deadline This position is anticipated to close on Jun 24, 2026. Equal Opportunity Employer 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. San Francisco Fair Chance Ordinance Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr Actalent