QA Documentation Associate I - 1st Shift

PCI Pharma Services; San Diego (CA); On-site; USD 28,000 - 30,000; Full time

Job summary

PCI Pharma Services in San Diego is seeking a QA Documentation Associate I to coordinate the review and approval of GMP documents using an electronic document management system. The role emphasizes accuracy, data entry, and timely archival of documents.

Candidates should have a high school diploma (associates preferred) and up to two years of relevant experience, plus familiarity with Microsoft Office. The position offers full-time hours, a 1st shift start, and a competitive benefits package.

Qualifications

• High School Diploma or equivalent required; Associates degree preferred.
• 0–2 years of relevant documentation experience.
• Familiar with Microsoft Office suite and data entry.

Responsibilities

• Coordinates document changes within an electronic document management system.
• Issues batch records, lab notebooks, and logbooks for GMP production and testing activities.
• Interfaces with authors and reviewers to process document changes on project timelines.
• Reviews QA/QC databases for documentation trends.
• Facilitates client review and approval of documents.
• Maintains document master copies and original production records.
• Supports archival projects per retention policy.
• Maintains regular full-time attendance and professional conduct.

Skills

Microsoft Office

Data entry

QA documentation

Education

High School Diploma

Associates degree preferred

Job description

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 I coordinates the review and approval of select GMP document types using an electronic document management system. Familiar with Microsoft applications and data entry. Manage the archival of company documents.

1st Shift

9AM

Essential Job Functions-other Duties May Be Assigned

• 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.
• Review of QA/QC data bases for trending documentation
• 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 to the retention policy.
• 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 Service’s cultural values and aligns daily actions with department goals and company culture

Education And Experience

• High School Diploma or equivalent required. Associates degree is preferred.
• Minimum of zero to two (0 - 2) years’ experience of relevant experience in documentation is required.
• Familiar with Microsoft office suite and data entry.

The hiring rate for this position is $19.54 -$21.98 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.

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.