QA Associate I

Responsibilities

• Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records).
• QMS process support for change controls and quality investigations.
• Performs AQL inspection of final filled product.
• Performs area line clearance operations in support of manufacturing operations.
• Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations.
• Generates labels for cGMP use.
• Reviews, approves, and reconciles labels for cGMP use.
• Sterile gown qualified to support cGMP activities in sterile suites.
• Affords assistance in the review and data entry of Calibration and Preventative Maintenance records.
• Affords assistance in the review of equipment and facility related Change Control documentation.
• Maintains equipment files and archives.

Qualifications

• High School Diploma or equivalent required.
• Bachelor’s degree in a Life Sciences discipline preferred.
• Zero to two (0-2) years of relevant experience in documentation, QA, or equivalent.
• Knowledge of cGMP regulations and good documentation practices preferred.
• Experience with Computerized Maintenance Management Software (CMMS) preferred.
• Demonstrated ability to follow detailed directions in a laboratory environment preferred.
• Ability to work independently, within prescribed guidelines, and as a team member.

Pay

The hiring rate for this position is $21.69 - $24.41 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.

Benefits

PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.