QC Specialist I, Investigations

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 QC Specialist - Investigations primary responsibility is to perform data analysis of environmental monitoring and facility monitoring data, and write quarterly trend reports to summarizing these data. Perform and author investigations for environmental monitoring excursions and deviations which occur during routine and aseptic operations. Write and revise cGMP documentation. Assist with corrective action plans.

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.

• Trend environmental monitoring data and preparation of trend reports

• Write and revise cGMP documents and technical reports to meet industry standards

• Initiating deviations/OOS/EEIs, CAPAs, and non-conformance investigations

• Perform data analysis and data review

• Other duties as necessary

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 to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to walk and drive between locations

• Ability to sit or stand for prolonged period of time

• Able to work in a highly complex environment with competing demands and priorities

• Able to deal with ambiguity

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Self-motivated and ability to work with minimal supervision

• Ability to meet aggressive deadlines while multi-tasking; excellent organizational and interpersonal skills

• Works closely with quality assurance, operations, and facilities staff

• <10%. Travel generally consists of routine daily movement between buildings

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.

• 1-3 years of GMP experience, including investigation, environmental trend reports, CAPAs

• Experience in pharmaceutical aseptic operations preferred

• BS/BA Degree in Scientific/Technical field (Microbiology preferred)

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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.