Document Control Specialist
MedixHouston, TX, United States14 hours ago
Job type
- Full-time
Job descriptionBachelor's degree in Life Sciences or related field. 4+ years of experience in document control or quality assurance within a regulated pharmaceutical or biotech environment. Strong understanding of cGMP, FDA 21 CFR Part 11, ISO standards, and other regulatory frameworks. Proficiency in document management systems and Microsoft Office Suite. Excellent organizational, communication, and problem-solving skills. Preferred : Experience with electronic quality management systems (eQMS). Preferred : Certification in document control or records management. Preferred : Experience supporting regulatory audits and inspections. Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances). Health Benefits / Dental / Vision (Medix offers 6 different health plans : 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)). 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1 / 1, 4 / 1, 7 / 1, and 10 / 1). Short Term Disability Insurance. Term Life Insurance Plan. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA). As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to : high-risk work environments (warehouse or industrial areas), high-risk / high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
Our client seeks a Document Control Specialist responsible for overseeing the creation, distribution, and maintenance of controlled documents. The role ensures compliance with cGMP, FDA, and other regulatory standards, while supporting cross-functional teams to maintain accurate and accessible documentation throughout the product lifecycle.
Key Responsibilities
- Develop, implement, and maintain document control policies and procedures aligned with regulatory and company standards.
- Manage the lifecycle of controlled documents including SOPs, Master Batch Records, protocols, validation reports, and change control documentation.
- Administer electronic document management systems (Master Control).
- Ensure timely issuance, reconciliation, and archival of GMP documentation.
- Conduct periodic reviews and audits of documentation to ensure accuracy, compliance, and data integrity.
- Collaborate with cross-functional teams to support documentation needs for manufacturing, quality, and regulatory submissions.
- Train and mentor staff on document control procedures and good documentation practices.
- Provide support during internal and external audits and inspections.
- Maintain records retention schedules and ensure compliance with company and regulatory requirements.
Qualifications
Benefits
Medix Overview :
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we're dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
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Document Control Specialist • Houston, TX, United States
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