Manufacturing Compliance Specialist (Pharma)| Hybrid

Manufacturing Compliance Specialist (Pharma)| Hybrid

Alpha Consulting | Devens, MA, US
Salary Range:$69,000 – $98,000 Salary range estimated by Zippia

Posted 12 days ago

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Description

*SENIOR MANUFACTURING COMPLIANCE SPECIALIST *
*DEVENS, MA*

*Hybrid Role.*

*Required Skills: *

* BS in chemical/biochemical engineering, biological sciences, or a related discipline with 2-4 years relevant experience (or equivalent).
* 1-4 years of experience in investigations.
* Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferred.
* Demonstrated basic project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required.
* Excellent verbal & written communications skills, including ability to present information clearly and concisely.
* Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization.
* Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment.
* Prior experience in/Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred.

*Project Description: *

* Conducts and manages resolution of deviations, root cause investigations, impact assessments and CAPAs as a Lead Investigator.
* Liaises with many different groups/organizations as a Lead Investigator.
* Proactively identifies and facilitates resolution of obstacles to timely completion.
* Proactively manages progression of investigation and CAPA to timely closure.
* Leads and participates in cross-functional investigation teams.
* Presents investigation findings to key stakeholders and site management.
* Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste.

This 12+ month position starts ASAP.

ALPHA'S REQUIREMENT #23-00133
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Types: Full-time, Contract

Pay: $40.00 - $45.00 per hour

Benefits:
* 401(k)
* Dental insurance
* Health insurance
* Health savings account
* Referral program
* Vision insurance
Schedule:
* Monday to Friday

Experience:
* bio-pharmaceutical manufacturing: 1 year (Required)
* root cause investigations/cGMP investigations: 1 year (Required)
* cell culture, recovery: 1 year (Preferred)

Work Location: Hybrid remote in Devens, MA 01434%11184355% %%legal%%