QA Associate I

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary:

The QA Associate I is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements. The Associate I promotes a cGMP environment and collaborates with internal team members to ensure adherence to specifications, processes, and procedures. The Associate I performs documentation review and ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.

Understanding and execution of basic cGMP and GDP principles is required

1st

Hours:

Start Time - 7AM or 8AM

• 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.
• Generate labels for cGMP use.
• Reviews, approves, and reconciles labels for cGMP use.
• Sterile gown qualified to support cGMP activities in sterile suites.
• Assists in the review and data entry of Calibration and Preventative Maintenance records.
• Assists in the review of equipment and facility related Change Control documentation.
• Maintains equipment files and archives.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.

• 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.

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.

• 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.

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose:
Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and…