QA Sr. Specialist GMP

Planet Pharma; Cambridge (MA); On-site; USD 76,000 - 83,000; Full time

Job summary

Planet Pharma is seeking an experienced QA professional in Cambridge, MA to oversee quality assurance for drug substance, drug product, and devices. The role involves reviewing batch records, regulatory filings, and production records, while supporting design verification and DHF deliverables.

Candidates should have a BS in life sciences and 5+ years QA GMP experience, with strong knowledge of FDA/EMA regulations. Excellent communication and organizational skills are essential for success.

Qualifications

• BS degree in life sciences, engineering or related field.
• 5+ years pharmaceutical QA experience in GMP manufacturing and supply chain.
• Good understanding of FDA and EMA regulations and guidelines.
• Excellent organizational, communication, and interpersonal skills.

Responsibilities

• 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 program.

Skills

Regulatory knowledge

GXP regulations

Teamwork

Independent work

Deadline management

Communication skills

Education

BS in life sciences

5+ years GMP QA

FDA/EMA regulations knowledge

Job description

Duties

• 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 program

Skills

• Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex 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