Manufacturing Change Specialist - Summer Intern

Nature and Scope

The Manufacturing Change Specialist Intern provides support to Manufacturing Supervision/Management as needed and is critical in maintaining compliance expectations for Corrective and Preventative Actions (CAPAs), Protocols, Change Controls, Annual Product Reviews (APRs), SOPs, and Media Fills. The Manufacturing Change Specialist Intern will participate in all aspects of the Document and Change Control Process. This includes all elements of the document lifecycle such as creation, editing, and reviewing Standard Operating Procedures and Product Masters, as well as initiation and execution of change controls for respective controlled documents as per applicable Standard Operating Procedures. The Document Control Coordinator works under the direct supervision of Manufacturing Quality Engineering and works collaboratively with the various Manufacturing and Quality Assurance departments.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Assist in the creation or revision of controlled documents including Standard Operating Procedures, specifications, protocols, product masters/modules, and other miscellaneous documents. Collaborate with department SMEs and incorporate applicable feedback into process and document changes.

• Assist in preparing controlled documents through the document and change control process including editing, proofreading, tracking, copying, distributing, scanning, and filing.

• Assist in performing training impact assessments for document change controls by reviewing module assignments and revising applicable document assessments.

• Ensure Change Controls for the process and document related changes are completed or extended before the due date while working with the QA Change Control team.

• Maintain regular communication with impacted departments for scheduled document effectiveness and associated required training for effectiveness.

• Assist in the Media Fill execution by reviewing and compiling batch record data, etc.

• Provide support for manufacturing projects (i.e. capital expansion project).

• Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures.

• Perform tasks with a minimal error rate. Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• High School Diploma or GED equivalent required.

• 1 year experience in editing controlled documents or relevant technical writing experience, required.

• 1 years' experience in a manufacturing environment required; pharmaceutical manufacturing, preferred.

• 1 years' work experience in an FDA regulated environment, preferred.

• Intermediate skills in Microsoft Word and Excel, required.

• Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision.

• Excellent organizational, interpersonal and communication skills (written and oral), required.

• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

• Must be self-motivated with the ability to manage, organize, and prioritize multiple tasks to meet deadlines.

• Ability to take feedback constructively and function in a team-oriented work environment.

• Ability to work overtime as needed.

Physical Environment and Requirements

• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected Hourly Rate:

$18.50 - $20.00

The hourly rate displayed is theminimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.