Contact Us

Use the form on the right to contact us.

You can edit the text in this area, and change where the contact form on the right submits to, by entering edit mode using the modes on the bottom right. 

9 Linnell Cir
Billerica, MA 01821
United States

1.978.667.4500

Employment

OPEN POSITIONS


RA Technical Writer

A growing medical device manufacturer of ophthalmic products is looking for a self-motivated individual to fill a full-time position in our regulatory affairs department.

Responsibilities (including, but not limited to):
• Prepares high quality regulatory submissions and supporting documentation for marketing applications.
• Reviews, edits, and inspects technical documentation to ensure continued compliance with regulatory requirements.
• Assists in the development of new product labels and IFUs and reviews current labeling for accuracy and completeness.
• Gathers, reviews, interprets, and prepares reports on post market surveillance activities.
• Develops, organizes, writes, and edits quality system standard operating procedures and records.
• Participates in regulatory surveillance audits and inspections (e.g. FDA, Notified Body)

Position Requirements:
• BA/BS in English, Journalism, Technical Writing or equivalent with a specialty in editing and writing. Minimum 1-2 years of relevant work experience.
• Excellent written and verbal communication skills, computer skills (Word, Excel, PowerPoint, etc.).
• Strong attention to detail (e.g. document style, consistency, grammar, and punctuation).
• Ability to interpret statistical data and prepare reports.
• Excellent analytical, organizational and time management skills.
• Experience in cross-functional collaboration.
• Experience producing high quality technical documents is a plus.
• Knowledge of ISO Standards, Quality System Regulations and European Regulations and Directives is a plus.
• All candidates must successfully pass a background check.

To Apply: Email resume to sstarbard@astp.com or send a fax to (978) 667-9778.


Entry-Level Lab Technician

Position Overview: Seeking a reliable temp-to-perm technician comfortable with performing lab duties in a clean room environment. Preferred individual possesses excellent manual dexterity, an eye for detail and the ability to take direction.

Qualifications:
- HS Diploma or equivalent, with the ability to read and follow detailed instructions.
- No Bachelor’s Degree required, will consider individuals with an Associate’s Degree.
- No experience necessary, we will train individuals on all lab duties.
- Must be able to lift 35lbs.
- Basic math skills are required.
- All candidates must successfully pass a background check.

To Apply: Email resume to sstarbard@astp.com or send a fax to (978) 667-9778.