Pharmaceutical Development/Technical Operations Technical Writer - Hybrid Bedford, MA Bedford, Massachusetts

Orbis Clinical is seeking a Technical Writer located in Hybrid Bedford, MA for up until the end of the year.

Job Title: Technical Writer

Location: Hybrid Bedford, MA

Contract: Up until the end of the year

Summary:

The Technical Writer will be a member of the Manufacturing organization responsible for the creation, revision, formatting, and maintenance of GMP documentation supporting Drug Substance and Central Services manufacturing operations.

Responsibilities:

• Documentation
  • Ensure high standards of cGMP documentation practices are always adhered to.
  • Author, edit, format, revise, and maintain SOPs, batch records, work instructions, forms, templates, and logbooks.
  • Coordinate document reviews and approvals through the document management system.
  • Manage document lifecycle activities including creation, revision, issuance, periodic review, and archival
• Miscellaneous
  • Ensure high standards of housekeeping are adhered to at all times.
  • Ability to drive closure of assigned internal/regulatory audit items as required.
  • Represent manufacturing in Project team meetings as required.
  • Ensure effective liaison and communication with other departments, maintaining good relations at all times.
  • Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite.
  • Ensure that objectives given are met in the appropriate agreed to timescale.

Requirements

• 2-3 years of experience with Document management systems preferred
• Experience with CAPA preferred
• Team-working skills and communication skills.
• Independently motivated and detail-oriented with good problem-solving ability.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $69.65 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.