QC Chemistry Associate II

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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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 QC Chemistry Associate II is responsible for conducting moderate to complex routine analysis of raw materials, proteins, peptides and small molecules under general supervision. The position may focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas: raw materials, in-process and finished formulations.

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

• Independently perform routine and moderately complex analysis and testing of raw materials, proteins, peptides, and small molecules, including compendial assays, USP Identification assays, AQL Inspection, UV-VIS, SoloVPE concentration assays, viscosity, Karl Fischer, and chromatography methods such as HPLC and cIEF.
• Perform documentation review and contribute to report writing with greater attention to detail and accuracy.
• Support and execute method transfer, qualification, and validation of new methods with minimal supervision.
• Maintain and update training documentation.
• Provide structured hands-on training as required.
• Lead or contribute to quality event deviation and investigation writing with a stronger analytical approach.
• Actively participate in the revision and collaboration of documents such as SOPs, protocols, and reports, ensuring process improvements and compliance.
• 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’s cultural values and aligns daily actions with department goals and company culture.

Special Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• constantly required to sit, and to reach to use computers and other office equipment
• constantly stand for extended periods of time, up to four (4) hours/time.
• frequently required to lift up to 40 pounds
• constantly required to view objects at close and distant ranges with hand and eye coordination
• frequently required to communicate with others
• Subject to passing a Visual Acuity test, depending on the Standard Operating Procedure (SOP) being performed, to ensure safety and accuracy.

Subject to passing a Visual Acuity test, depending on the Standard Operating Procedure (SOP) being performed, to ensure safety and accuracy.

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

Qualifications:

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

• High School Diploma required. Bachelor’s degree in a Life Sciences discipline or equivalent preferred required.
• Minimum of two (2) years of relevant experience required.
• Ability to perform testing in a highly accurate and reproducible manner.
• Adhere to GMP guidelines and SOPs.
• Preferred experience in LIMS and QMS software.
• Possess good Analytical skills and understanding of Quality systems and regulations.
• Strong communication and teamwork.

• The hiring rate for this position is $26\.73-$30\.07 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.