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 is seeking a Documentation Specialist to operate within Pharmacy Operations/Manufacturing, focusing on administrative and documentation tasks. This role involves authoring, formatting, and maintaining cGMP-compliant sterile compounding documentation, including SOPs and deviations, to ensure accuracy, clarity, consistency, and inspection-readiness. The specialist will also support day-to-day communication and training administration across the facility, partnering with Production, Quality Assurance, Compounding, and Regulatory Compliance.
Key Responsibilities
- Work within Pharmacy Operations/Manufacturing primarily in an administrative and desk capacity.
- Author, format, and maintain controlled documentation that supports cGMP-compliant sterile compounding operations.
- Partner with Production, Quality Assurance, Compounding, and Regulatory Compliance to ensure Standard Operating Procedures (SOPs), deviations, and supporting records are accurate, clear, consistent, and inspection-ready.
- Support day-to-day communication and training administration across the facility.
Qualifications
- Pharmacy Tech with IV Certification OR candidate with QA Pharma experience.
- Working knowledge of cGMP principles and good documentation practices (ALCOA+).
- Ability to manage multiple projects and deadlines independently.
- Experience in sterile compounding, a 503B outsourcing facility, or a cleanroom environment preferred.
- Familiarity with USP <797>, USP <800>, and DEA controlled substance documentation preferred.
Experience
- 2+ years of technical writing or documentation experience in a regulated environment (pharmaceutical, biotech, medical device, or similar).
- Experience with electronic quality management or document control systems (eQMS/LMS).
- Prior experience writing deviations, investigations, or CAPAs.
Skills
- Excellent written and verbal communication skills with strong attention to detail.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Experience with Visio or similar tools for flowcharts and process diagrams.
- Graphic design skills (Canva, Adobe, or PowerPoint) for posters and announcements.
Education
- Bachelor's degree in Life Sciences, Pharmacy, English, Communications, or a related field, or equivalent experience.
Additional Requirements
- Schedule: 8am-5pm, Monday-Friday.
Benefits
- 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 understand that you may not have all of the requested qualifications and/or skills for this position. If you are interested in this position, we encourage you to apply. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
*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).
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.
Any required state or Joint Commission training is compensated at the state or local minimum wage rate.
*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.