QC Chemistry Associate III - 2nd 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.

Summary

This position is responsible for conducting routine analysis of in process, release and stability assays for proteins, peptides and small molecules under general supervision. The role may focus in a specialized area and provide routine analysis, data review, and testing according to standard operating procedures in any of the following areas: Sample testing and release development of assays and performing qualifications.

Hours: 2nd Shift

2:00 PM -10:30 PM

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 conducts and reviews routine and complex analysis and testing of samples with minimal supervision, often specializing in a specific QC area while providing technical guidance to junior team members.
• Independently performs release testing assays for in-process, final product, raw materials, stability, and other routine samples, demonstrating proficiency in compendial assays, USP Identification assays, AQL Inspection, UV-VIS, SoloVPE concentration assays, viscosity, Karl Fischer, and chromatography methods such as HPLC and cIEF.
• Performs complex assays, including ELISA, plate-based assays, HPLC, LC-MS, and CE-SDS, with a strong ability to troubleshoot and optimize methods as needed.
• Adheres to cGMP requirements and SOPs.
• Compiles data for documentation of test procedures.
• Reviews batch records and specifications as required.
• Generation and collaborator Standard Operating Procedures (SOPs) for internal use and client specific methods.
• Collaborates on and participates in the transfer, qualification and validation of new testing methods with guidance from supervisor, which may include writing protocols and reports
• Trains junior personnel on quality control methods and SOPs.
• Participate in Client Interface meetings as may be required or necessary.
• Technical writing of investigations for deviations and Out of Specifications (OOSs)
• 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.
  
  

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 strongly preferred in a Life Sciences discipline or equivalent.
• Minimum of four (4) years of relevant experience in a laboratory setting.
• Experience with GMP, aseptic techniques, troubleshooting, and data entry.
• Preferred experience in LIMS and QMS software.
• Ability to perform testing in a highly accurate and reproducible manner.
• Proficiency with Microsoft Office applications.
• Detail oriented with strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Demonstrated ability to follow detailed directions in a laboratory environment.
  
  

The hiring rate for this position is $29.65 - $33.36 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.

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.