Drug Product Manufacturing Associate I - 1st Shift

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.

The Manufacturing Associate I is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

• Train in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility.

• Train on required SOP's and execute training curriculum.

• Prepare materials needed for aseptic operations.

• 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.

• Performs various routine manufacturing tasks on complex equipment under the guidelines of established SOP’s and cGMP regulations.

• Accurately documents data and completes batch records as needed.

• Reliably executes well defined SOP’s.

• Operates in clean room environments in accordance with established policies and procedures.

• Collects and disposes of lab wastes according to established procedures.

• 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.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• High school diploma required. Bachelors 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:
While performing the duties the employee is:

• occasionally required to sit, and to reach to use computers and other office equipment

• occasionally stand for extended periods of time, up to four (4) hours/time

• occasionally required to lift up to 40 pounds

• constantly required to view objects at close and distant ranges

• frequently required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

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

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