Manufacturing Investigator I

Job description

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. We are currently looking for a Manufacturing Investigator I. Under direct supervision, this position may investigate, author, coordinate, and revise deviations, corrective and preventative actions, complaints, and other cGMP documents such as Master Production Batch Records. The Manufacturing Investigator I supports simple write-ups and the resolution of issues or risks related to Manufacturing. This role works with multiple departments, and may coordinate the review, revision, and approval of procedures and associated documentation. Essential Duties and Responsibilities: Under direct supervision, initiates and supports the timely completion of investigations and resolution of issues related to Operations. May support cross-functional teams. Authors and revises batch records, deviations, complaints, and other technical documentation. Manages specific components of large-scale deviations. Tracks and trends relevant documentation and data as specified. Maintains a GLP/cGMP environment and follows SOPs. Adjusts responsibilities and activities to meet client and internal expectations. Follows up on open documents to ensure timely close out of batch record revisions and investigations. Provides support for internal and client audits as needed. Becomes familiar with new equipment, systems, and technologies to create and maintain accurate documentation. 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 Services cultural values and aligns daily actions with department goals and company culture. Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures Qualifications: Associate’s or bachelor’s degree preferred. High School diploma or equivalent required. 1-2 years of relevant experience in manufacturing. Minimum of 1 year of relevant experience in cGMP environment preferred. Previous investigations experience preferred. Familiarity with relevant technical documentation (SOPs, preventative actions, deviations, etc.) preferred. Detail oriented with strong English writing skills. Strong verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Highly proficient with Microsoft Office applications. *The hiring rate for this position is $19.54 -$21.98 per hour 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. #LI-KC1 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.