Chemistry, Manufacturing and Controls (CMC) Writer, Validation Job Opening

ROLE SUMMARY

Author and/or edit Chemistry, Manufacturing, & Control (CMC) sections for new product submissions and submissions impacting commercial products in conjunction with validation subject matter experts. Supports Regulatory with Board of Health (BOH) inquiry responses and supports Pre-Approval Inspections (PAI) and other regulatory inspections as required. Supports completion of post approval submission commitments.

ROLE RESPONSIBILITIES

• Create and manage CMC templates specific to the McPherson areas and processes.
• Authors CMC sections for new product submission and CMC sections for submission impacting commercial products
• Work with regulatory on board of health (BOH) inquiry responses
• Qualified candidates will serve as technical writing resource for the validation department and project teams. Individual will be the primary authors, and reviewers of regulated documents such as validations, in-process control strategy, and comparability sections.
• May support PAIs and other regulatory inspections
• Complete document updates resulting from deficiency/inquiries and own the change record for associated change, as appropriate
• Knowledgeable on submission information in electronic document system (GDMS) and support the site in accessing those documents.
• Supports Site Compliance Network Member with regulatory documents need for associated change records
• Support update of Site Mater File, as directed

BASIC QUALIFICATIONS

• High School Diploma required.
• No Degree, 5+ years of proven cGMP Validation or Laboratory (test method validation, compendial updates) experience
• Ability to work independently with limited managerial oversight
• Good written and oral communication skills
• Good Technical writing skills

PREFERRED QUALIFICATIONS

• Bachelor’s degree in Engineering, Science with 3+ years of cGMP experience strongly preferred
• 3-5 years prior Validation experience
• Experience in authoring CMC submission documents
• GMP Experience
• Strong understanding of GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for IQ/OQ/PQ and Standard Operating Procedures

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

• Last Date to Apply for Job: July 5, 2019
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.