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 I - Investigation's 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 documentations and applicable protocols. Assist with change controls and corrective action plans.

JOB DUTIES

• Trend environmental monitoring data and preparation of trend reports
• Write and revise cGMP documents, protocols and technical reports to meet industry standards
• Initiate deviations/OOS/EEIs, CAPAs, Change controls and non-conformance investigations
• Perform data analysis and data review
• Other duties as necessary

PROFESSIONAL SKILLS

• Proficient in Microsoft Office including Word, Excel and Powerpoint
• Good written and oral communication skills are required; proficiency in English language

EXPERIENCE

• 3-5 years of GMP experience, including investigation, environmental trend reports, CAPAs, change control
• Experience in pharmaceutical aseptic operations preferred

EDUCATION

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

QUALITIES

• Self-motivated and ability to work with minimal supervision
• Ability to meet aggressive deadlines while multi-tasking; excellent organizational and interpersonal skills

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• 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

COMMUNICATIONS & CONTACTS

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

TRAVEL

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

#LI-LL1

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.