QA Associate III

Responsibilities

• Aids in the timely completion of open investigations and investigation activities.
• Ensures the adequacy of investigations performed to support the batch release process.
• Supports the review and approval of quality reports including deviations, OOSs, complaints, OOTIs, SCARs, and CAPAs.
• Generates and compiles lot file review documentation for batch disposition.
• Updates lot status in ERP system.
• Performs equipment inductions, revisions, and record maintenance within the electronic database.
• Reviews and approves validation protocols and reports.
• Performs logbook documentation audits for cGMP regulated logs and SOPs.
• Creates, revises, and approves procedures.
• Reviews and approves change control documentation.
• Assists with internal, client, and regulatory audits.
• Assists with generating department metrics.
• Develops recommendations for continuous improvement projects.
• Reviews and approves production batch records and associated data for product disposition.
• Assists in the review and approval of controlled documents including standard operating procedures, protocols, and reports.
• Ensures regular and reliable attendance.
• Behaves professionally with both internal and external business associates.
• Fosters a safe and environmentally sustainable workplace.

Requirements

• High School Diploma or equivalent.
• Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
• Minimum of three to five (3-5) years of relevant GMP experience in documentation, QA on the floor, manufacturing, or equivalent.
• Knowledge of cGMP regulations and good documentation practices preferred.
• Strong organizational and analytical skills.
• Familiarity with Microsoft Office applications.

Qualifications

• Must be able to work independently and as part of a team.
• Can lead projects and train junior staff.

Skills

• Excellent organizational and analytical skills.
• Strong attention to detail.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office applications.

Benefits

PCI offers a competitive benefits package that includes:

• Paid time off
• Health insurance coverage (including dental and vision)
• Flexible spending account
• 401(k)