Senior QMS Investigator & Compliance Lead

PCI Pharma Services; San Diego (CA); On-site; USD 37,000 - 41,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

PCI Pharma Services in San Diego, CA seeks an Investigator to write and manage out-of-specifications, deviations, CAPAs, and SOPs within a CGMP framework. You will support cross-functional teams and drive timely document closure to enable product release.

The role emphasizes quality systems, risk assessment, and continuous improvement while following PCI EHS policies. Relevant aseptic and GMP experience is essential for success.

Qualifications

• High School diploma or equivalent required. Bachelor's degree in Life Sciences or a related field preferred, or equivalent combination of education and/or relevant work experience will be considered.
• 5-7+ years of relevant experience in a CGMP environment, Manufacturing preferred.
• Has strong understanding of equipment, systems and technologies that enable issues to be translated using accurate documentation.
• Previous experience with investigations is required.
• Previous experience writing technical documentation (deviations, corrective and preventative actions, SOPs, etc.) is required.
• Relevant aseptic processing and compliance experience required.
• Must have a solution-based attitude. Aseptic gowning experience and mechanical aptitude are preferred.
• Strong listening and interpretive skills to successfully translate events into clearly written documents.
• Detail-oriented with very strong English writing skills.
• Strong verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.

Responsibilities

• Initiates and/or supports semi-complex investigations and resolution of issues and/or potential problems related to QMS and/or Operations/Production.
• Coordinates and supports interdisciplinary working teams with recommendations, advice, and action plans for semi-complex investigations, change controls, gap analyses, and risk assessments.
• Authors and revises change controls and other technical documentation.
• Manages specific components of large-scale deviations.
• Tracks and trends 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/records to ensure close out of investigations to enable product release in a timely manner.
• Provides support to internal, client, and regulatory audits as needed.
• Participates in limited discussions with clients regarding investigations.
• 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.
• Performs other duties as assigned to support departmental and organizational objectives.

Skills

Investigation experience

Technical writing

Aseptic processing

English writing

Communication skills

Independent work

Attention to detail

Education

High School diploma or equivalent

Bachelor's degree in Life Sciences or related field

Equivalent combination of education/experience considered

Job description

PCI Pharma Services in San Diego, CA seeks an Investigator to write and manage out-of-specifications, deviations, CAPAs, and SOPs within a CGMP framework. You will support cross-functional teams and drive timely document closure to enable product release.

The role emphasizes quality systems, risk assessment, and continuous improvement while following PCI EHS policies. Relevant aseptic and GMP experience is essential for success.