QMS Investigator III

About the role

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 position investigates and writes out-of-specifications, deviations, preventive actions, change controls, and other related cGMP documents under minimal supervision. The role supports semi-complex investigations and resolution of issues/potential problems related to Operations/Production.

The position writes and edits standard operating procedures (SOPs), change controls, and other related CGMP documents. This position works cross-functionally to coordinate the review, approval and revision of procedures, documents, specifications and forms. The Investigator will work with multiple departments and CGMP disciplines, such as Manufacturing operations, Quality Control, Microbiology, Facilities, and Quality Assurance.

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.

• 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.

While performing the duties the employee is

• constantly required to sit, and to reach to use computers and other office equipment
• occasionally stand for extended periods of time, up to four (4) hours/time.
• occasionally required to lift up to 10 pounds
• frequently required to view objects at close and distant ranges with hand and eye coordination
• constantly required to communicate with others

Additional information

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio-hazardous materials. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast-paced and demanding.

This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required.

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.
• Must be highly proficient with Microsoft Word and Excel.

Additional information

Please Note: This is an evergreen posting intended to build a pipeline of qualified candidates for current and future opportunities. Candidates may be contacted as business needs arise.

• The hiring rate for this position is $26.73 - $30.07 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.

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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future