Manufacturing Investigator I (Batch Record Author)

SUMMARY:

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 JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

• 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.

EDUCATION AND EXPERIENCE:

• Associate's or bachelor's degree preferred. High School diploma or equivalent required.

• 0-2 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.

PHYSICAL DEMANDS:

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

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

WORK ENVIRONMENT:

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. 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.

*The hiring rate for this position is $19.54 -$21.98 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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