QA Compliance Specialist II

Overview

GENERAL SUMMARY OF POSITION:

The QA Compliance Specialist II is responsible for ensuring that quality standards are met in MassBiologics cGMP manufacturing facilities by performing a wide variety of activities to assure compliance with applicable regulatory requirements. These activities include, but are not limited to: assisting with audits, data and documentation reviews, and analyses.

Responsibilities

MAJOR RESPONSIBILITIES:

• Facilitate the review and approval of deviation reports; ensures appropriate corrective actions are assigned.
• Writes environmental monitoring and water excursion reports; ensures appropriate corrective actions are assigned, provides periodic reports to management on status.
• Assists with periodic internal audits of production and laboratory areas; assists with contract manufacturing audits
• Review and approves Standard Operating Procedures and corresponding in-process forms.
• Review and approves reactivation of GMP manufacturing areas after preventive maintenance, unplanned maintenance, and shut down.
• Performs batch record review for compliance to cGMPs and internal requirements. Assists in providing training for facility staff on GMPs, GLPs, and internal QA procedures.
• Performs other additional job related duties as required.

Qualifications

REQUIRED QUALIFICATIONS:

• Requires a bachelor’s degree with a minimum of 2 years of relevant experience or equivalent
• Ability to follow instructions precisely and recognize deviations.
• Prior experience in a cGMP regulated environment. Strong working knowledge of GMPs and Quality systems.
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines.
• Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
• Excellent written and verbal communication skills. Ability to provide basic feedback on compliance documents. Ability to communicate effectively (up, down, and laterally) with others
• Demonstrated initiative through past experience
• Ability to work effectively both independently and as a member of a team.
• Must possess the ability to interpret and apply current GMP regulations and internal Quality policies consistently.