QA Documentation Associate II

About the job

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 Documentation Associate II will coordinate the review and approval of SOP’s, master batch records, methods, material specifications, protocols, reports and other GMP documentation using an electronic document management system. The role will work with Project Managers and Subject Matter Experts to revise existing master batch records for process change, corrective actions, and clerical document errors. The QA Documentation Associate II also supports administrative responsibilities for the team, including scanning documentation, maintaining spreadsheets for in-process projects, and manage the archival of company documents.

• ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:
• Utilize Quality Management systems and employee resource programs for daily tasks and collaboration.
• Monitors QA and QC databases for trending documentation.
• Coordinates document changes within an electronic document management system.
• Issues batch records, laboratory notebooks, and logbooks for use in GMP production and testing activities.
• Interfaces with document authors and reviewers to process document changes within project timelines and in accordance with established procedures.
• Facilitates client review and approval of documents.
• Ensures proper maintenance of document master copies and original production records.
• Assists with the archival project in accordance with the retention policy.
• Tracks and electronically files document errors for use in document revision.
• Maintains a GMP environment and follows all Standard Operating Procedures (SOP’s).
• 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 Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

• EDUCATION AND EXPERIENCE:
• High School Diploma or equivalent required; Associates degree preferred.
• Minimum of 2-4 years of relevant experience in documentation, quality assurance or equivalent.
• Familiarity with cGMP guidelines.
• Familiar with Microsoft Office applications and data entry.
• Ability to work independently or as a team member.
• Detail oriented and strong written and verbal communication skills.

The hiring rate for this position is $24.08 - 27.09 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.

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
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 programs, marketing approach, and workplace culture.