Document Control Specialist - San Diego, California | CareerCircle
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Document Control Specialist

Actalent

02/22/2022

Posting ID: JP-002663833

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San Diego, California
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Description:

1. Compose and review technical documentations such as technical reports, development reports, risk assessments, DOE protocol/reports, process validation protocol/reports. 2. Provide support to Regulatory Department to prepare CMCs. 3. Supporting all activities related to Document Control in GMP Manufacturing. 4. Controlled document preparation, routing and issuance, supporting Document Creation/Change system. 5. Issuing controlled copies of released documents (forms, procedures, production batch records etc.) to manufacturing department upon request. 6. Reviewing GMP notebooks and logs prior to submitting to Quality Assurance for archiving. 7. Reviewing all scientific and technical data on Production Batch Records after GMP production. 8. Obtain corrections on documents from GMP personnel in the laboratories and office area. 9. Complete and submit all required documents to Quality Assurance for drug substance release. 10. Supporting Management during regulatory agency and customer audits and visits. 11. Represent PolyPeptide Group with a high level of integrity and professionalism. 12. Adhere to PolyPeptide Group policies and support Management decisions in a positive, professional manner. 13. Other manufacturing document control related tasks as applicable. 1. Organizing and maintaining all GMP documents (i.e. Production Batch Records, notebooks, logbooks and forms) in the GMP laboratories and office area.

Skills:

Doc Control, QA, gmp environment, batch record, GMP, Reporting, technical report writing

Top Skills Details:

Doc Control,QA,gmp environment,batch record

Additional Skills & Qualifications:

1. Ability to work within the PPL safety guidelines. 2. Good written and oral communication skills; ability to communicate effectively and project a professional image when giving and taking information in writing, in person, and over the phone. 3. Accurate typing/keyboarding skills; solid computer skills, including the use of word processing and spreadsheet software applications. 4. Ability to take initiative and prioritize tasks; good time-management, problem prevention, and problem-solving skills. 5. Knowledge of cGMP, specifically, ICH Q7. 6. Sufficient technical background and understanding to review Production Batch Records and other GMP documents. 7. Ability to work independently and as part of a team; ability to motivate self. 8. Ability to work accurately with close attention to detail. 9. Ability to maintain confidentiality of sensitive information. 10. Ability to work with co-workers, customers/clients and outside agencies professionally and tactfully. 1. Associates degree as a minimum; Bachelor's degree in Chemistry or Biochemistry preferred. 2. One year experience in a regulated industry as a minimum. 3. GMP laboratory and documentation experience preferred. 4. Experience in scientific technical writing preferred, but not required.

Experience Level:

Entry Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Jennifer Martin

Phone: +18588772631

Email: jennmartin@actalentservices.com

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