QA Sr. Specialist GMP

Reference: 631968

Posted:

Location:

Cambridge, Massachusetts Company:
Planet Pharma Group Contact:
Applications Email: applicationsDuties

* Review of event documentation such as Batch records, Exceptions, and Regulatory filings

* Production record review and Product disposition for drug substance, drug product, device assembly and finished goods

* Support design development plan including design verification and DHF deliverables

* Build and maintain Product Specification Files (PSF) for the companies programSkills

* Knowledge of relevant government regulations and agency rules for labeling (CFR & Eudra Lex Volume 4, Annex 13)

* Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.

* Demonstrated teamwork, initiative, and problem-solving skills

* Ability to prioritize and work independently with minimal supervision

* Ability to accurately determine deadlines and ask for help if needed

* Detail oriented with solid problem-solving acumen.

* Ability to work effectively in a team environment with great organization skills.

* Ability to independently analyze and reconcile moderate to complex issues.

* Must have demonstrated initiative and accountability in a fast-paced environment.

* Excellent verbal and written communication and interpersonal skills.

* Proficient with computers and word processing software (i.e., Microsoft Office products)
Education

* Minimum, a BS degree in life sciences, engineering or related field

* Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment

* Good understanding of FDA and EMA regulations and guidelines

* Excellent organizational, communication, and interpersonal skills.

Pay ranges between 55-60/hr based on experience