QA Documentation Associate I - 1st Shift

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

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Flexible spending account

Job summary

PCI Pharma Services in San Diego is seeking a QA Documentation Associate I to coordinate review and approval of GMP documents within an electronic document management system. You will work with document authors and reviewers to ensure timely processing of changes.

Minimum 0–2 years of documentation experience is required; a High School Diploma is required with Associates degree preferred. Proficiency in Microsoft Office and data entry is essential.

Qualifications

• High School Diploma or equivalent required; Associates degree preferred.
• Zero to two 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.
• Interfaces with authors and reviewers to process document changes on schedule.

Skills

Microsoft Office

Data entry

Document control

Attention to detail

Education

High School Diploma or equivalent

Associates degree preferred

Tools

Electronic document management system

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.

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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.