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PCI Pharma Services

QA Documentation Associate I - 1st Shift

PCI Pharma Services · San Diego, California, United States · $41K–$46K/yr

Pharmaceutical Manufacturing · 5,001-10,000 employees

Yesterday
Junior (0-2 yrs) Full-time United States
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About the role

The QA Documentation Associate coordinates the review and approval of GMP documents using an electronic management system. They are also responsible for issuing batch records, managing document archival, and facilitating client reviews.

What they look for

Document management GMP compliance Data entry Microsoft office suite Quality assurance Quality control Record keeping Archival management Batch record issuance Laboratory notebook management Logbook management Documentation review Regulatory compliance

Requirements

Candidates must have a high school diploma or equivalent, with an associate degree preferred. A minimum of zero to two years of relevant documentation experience and proficiency in Microsoft Office are required.

Benefits

Paid time off Health insurance Dental insurance Vision insurance Flexible spending account 401(k) plan Annual performance bonus

Full 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.

#LI-AC1

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.