Job#: 2069215
Job Description:
Seeking a Technical Writer (Chemist) to join a Pharma company in Wisconsin.
SUMMARY:
The incumbent supports the operations group and specifically the process engineering/Chem Development/Operations group in writing and maintaining production records. This includes, but is not limited to, preparing batch log records, cleaning log records, deviations, work instructions, RM specs, Intermediate specs, API specs and other documents as needed.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
-Works closely with Process Engineering, Quality Systems, and Operations departments.
-Organizes material and completes assignment according to set standards regarding order, clarity, style and terminology.
-Edit, standardize, or make changes to material prepared by others to improve ability of reader to more clearly understand.
- Work to create and maintain standardized templates for production records
-Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance.
-Implements and adheres to all applicable SHE, DEA, and cGMP regulations.
-Provide assistance with projects as needed and as assigned by the Head Chem Dev.
-Ability to translate verbal and generic technical process descriptions into detailed written instructions.
EDUCATION AND EXPERIENCE:
-A degree in Chemical Engineering, Chemistry, or other technical degree in addition to 1-3 years’ experience in a pharmaceutical organization are required.
-Experience with tech transfers as well as in-depth knowledge of process engineering and cGMP regulations are required.
OTHER REQUIREMENTS:
-Must have excellent verbal and written communication skills.
-Must be able to work efficiently with people of all levels and cultures.
-Must be a team player.
-Must be highly organized and must be very conscientious and detail-oriented.
-Must be a self-starter and initiator.
-Must have good computer skills (word, spreadsheet, presentation).
-Must be able to manage several complex projects/issues simultaneously
-Must have good interpersonal skills with an ability to negotiate.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.