Introduce yourself
We'll guide you from there!
Way to kick of your application with the best life sciences recruitment partner you’ll meet!
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.
The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.
