Pfizer Brentwood, MO, USA
Aug 16, 2017
**ROLE SUMMARY** The Work Team Enabler is responsible for managing and controlling the workflow of critical cGMP production documentation. The incumbent will generate, distribute, track, and control production batch records in Sterile Process Manufacturing (SPM) before final handoff to the Quality unit. The position will manage SPM production logbooks and other associated documentation as directed by the business unit manager. In addition, the position will provide support for training and training-related documentation. **ROLE RESPONSIBILITIES** Coordinates delivery and return of production records for use and execution. Performs post-execution documentation review of production batch records and controls/manages the flow of batch records between Operations and Quality. Orders supplies as needed to support production. Manages post-execution production batch record and log book review/corrections workflow within SPM. Responsible for annual record retention of production documents (logs, forms, records, etc.) Manages SOP periodic reviews or other annual review for the respective Operations unit. Conducts general inspections for cleanliness. Supports PLS/training-related activities and associated documentation. Compiles and posts metrics for display with the respective Operations area. Supports SPM operations by ensuring applicable safety guidelines/policies are followed and that tasks are conducted in accordance with appropriate processing standards, such as FDA's current Good Manufacturing Practices (cGMPs). The successful candidate possesses the ability to work with minimal supervision and accomplish assigned tasks in a timely manner. **QUALIFICATIONS** High school diploma / general education degree (GED) plus either an Associate's degree or twelve months work experience (e.g. current or previous Pfizer colleague; Manufacturing, Packaging or Veterans/Military relevant experience). 1-2 years of pharma experience is preferred with an understanding of cGMPs and Good Documentation Practices. Basic administrative and/or standardized, semi-skilled work routines; operation of non-complex technical and/or mechanical tools and equipment. Advanced proficiency in Microsoft Office applications and basic knowledge of ERP systems preferred. Demonstrated interpersonal leadership and accountability in day-to-day interactions with an operational focus on customer needs and process requirements is required. Considerable demonstrated skills in communicating (oral and written) effectively with diverse individuals/groups; facilitating trust and understanding; and developing, influencing and managing work, employee and customer relationships. **PHYSICAL/MENTAL REQUIREMENTS** This position routinely requires sitting, standing, and walking throughout the SPM area. Accessing workplaces by climbing stairs is required. In addition, occasional weekend and overtime hours are necessary. Use of eye protection, gloves and other PPE is required. Maintaining aseptic area certification may be required. Aseptic gowning procedures will be required. Aseptic gowning requires all body parts to be completely covered (gowned) for substantial periods of time. Practices and promotes safe working environment at all times **.** **EEO & Employment Eligibility** (KING SITES ONLY) 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. This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees **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 + **Last Date to Apply for Job: 5 September, 2017** + **This job is (Pfizer) (Non-exempt) (US/PR) Grade: 003** A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.