Jobs · Analyst · California

Drug Product Manufacturing Associate I - 2nd Shift

PCI Pharma Services · San Diego, CA · 2 wk ago
AnalystFull-time

About the role

The Manufacturing Associate I plays a crucial role in the production of injectable pharmaceuticals within a GMP regulated facility. This position requires adherence to strict SOPs and cGMP regulations.

Responsibilities

  • Train in one or more areas of aseptic manufacturing injectable pharmaceuticals using GMPs in FDA-regulated facilities.
  • Execute training curriculum and prepare materials needed for aseptic operations.
  • Operate equipment such as glasswashers, autoclaves, depyrogenation ovens, and automated filling machines under the guidelines of established SOPs and cGMP regulations.
  • Accurately document data and complete batch records as needed.
  • Operate in clean room environments in accordance with established policies and procedures.
  • Collect and dispose of lab wastes according to established procedures.
  • Reliably execute well-defined SOPs.
  • Communicate effectively with others in a manufacturing GMP environment.
  • Exhibit 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.
  • Embody PCI Pharma Service’s cultural values and align daily actions with department goals and company culture.

Qualifications

  • High school diploma required.
  • Bachelor's degree in a science or engineering discipline preferred.
  • Minimum of zero to two (2) years of relevant experience in manufacturing, laboratory, mechanical, or engineering positions.
  • Ability to follow instructions with direct supervision.
  • Detail-oriented with strong written and verbal communication skills.
  • Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
  • Familiarity with cGMP, manufacturing, machine operations, and data entry.
  • Must be familiar with Microsoft Office applications.

Physical Demands

  • Sit occasionally.
  • Reach to use computers and other office equipment occasionally.
  • Stand for extended periods of time, up to four (4) hours/time occasionally.
  • Lift up to 40 pounds constantly.
  • View objects at close and distant ranges frequently.

Pay and Schedule

Hiring rate: $21.98 - $25.65 per hour 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.

Benefits: Full-time employees receive 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.

Benefits

PCI offers a comprehensive benefits package designed to support the diverse needs of our employees. This includes:

  • Paid time off
  • Health insurance coverage (including dental and vision)
  • A flexible spending account
  • A 401(k) plan

Schedule

Second shift hours generally Monday through Friday from 2:00 PM to 10:30 PM.

Skills

Essential skills for this role include:

  • Training in aseptic manufacturing
  • Operating GMP equipment
  • Data documentation
  • Communication with colleagues
  • Adherence to SOPs and cGMP regulations

Benefits

PCI Pharma Services offers a range of benefits to support the well-being and career growth of its employees, including:

  • Paid time off
  • Health insurance coverage (including dental and vision)
  • A flexible spending account
  • A 401(k) plan

Pay

The hiring rate for this position is $21.98 - $25.65 per hour 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.

Schedule

Second shift hours generally Monday through Friday from 2:00 PM to 10:30 PM.

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