Specialist, Compounding Operations Documentation

Key Responsibilities

Documentation Development & Maintenance

• Assist in drafting, revising, and formatting manufacturing documentation, including SOPs, work instructions, logs, forms, and compounding protocols.
• Ensure document revisions are properly controlled, approved, and issued in alignment with document control procedures.
• Maintain documentation archives and ensure real-time filing and retrieval practices.

Compliance & USP Standards

• Ensure all documentation activities are aligned with regulatory requirements (FDA, EU, etc.) and internal QMS standards. Maintain compliance with USP <795>, <797>, and <800> (as applicable) and other regulatory guidelines.
• Participate in audits and inspections by preparing and presenting relevant documents upon request.
• Support data integrity initiatives and ensure adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).

Training & Compounding Support

• Collaborate with production and quality teams to support continuous improvement of documentation processes.
• Partner with compounding operators and supervisors to identify points for training.
• Help transition paper-based processes to electronic formats (if applicable).

Qualifications

• Bachelor’s degree in English / Communications, Technical Writing / Tech Comm Pharmaceutical Technology, Chemistry, Pharmacy or a related field.
• Strong knowledge of USP 795 and 800, cGMP, GDP, and compliance
• Detail-oriented with excellent proofreading and technical writing skills.
• Proficiency in Google Suite and experience in Asana, SmartSheet

Preferred Skills

• Working familiarity with compounding processes, equipment, and terminology.
• Experience in electronic batch records (EBR) and manufacturing execution systems (MES).
• Ability to handle multiple priorities with a strong sense of urgency and accuracy.
• Strong interpersonal and communication skills, especially when liaising between Compounding and QA teams.
• Good Manufacturing Practices (cGMP) experience.
• 3-5 years of experience in a cGMP manufacturing environment, preferably with compounding or formulation experience.
• Document control systems (e.g., MasterControl, Veeva, Agile) experience.

Work Environment & Physical Requirements

• Office and manufacturing environment exposure.
• May require gowning and entry into classified cleanroom areas.
• Occasional standing, walking, and observation of floor activities required.
• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting 80% of the time for up to a twelve-hour shift. Must be able to lift up to 50lbs.

Benefits

Our Benefits (There Are More but Here Are Some Highlights):

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

Conditions of Employment

• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match.

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.

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