The Technical Writer I is accountable for driving results in a fast-paced environment by working with multiple Project Managers and teams to establish priorities and ensure that all appropriate technical correspondence flowing out of the organization is accurate, organized and complete. The Technical Writer I will draft, update and track all documentation routing through appropriate reviewers to ensure timely flow through all required departments and publish monthly performance metrics. This role will work closely with Project Managers, Technical Managers, CR&D, AR&D, QC, QA, Production and Manufacturing to ensure smooth initiation of cGMP Projects. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile.
Your Responsibilities
Ensures Master Production Records (MPRs), Production Summaries (PS), and Master Cleaning Records (MCR) are drafted in such a manner that clearly describes the process and captures all data required in Sterling's format and a cGMP compliant manner based on a detailed Technical Package from the Development Team or other acceptable written procedure.
Coordinates and facilitates document Group Review meetings and tracks all documentation routing through appropriate reviewers to ensure timely flow through all required departments and publish monthly performance metrics.
Works with multiple Project Managers and teams to establish priorities.
Works closely with Project Managers, Technical Managers, CR&D, AR&D, QC, QA, Production and Manufacturing to ensure smooth initiation of cGMP Projects.
Participates in client communications, such as site visits and teleconferences as necessary.
Provides written and verbal updates to Project Managers or other department heads as necessary.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
Requirements for the Role
Bachelor's degree in Physical or Life Science or equivalent (Preferred); OR
Associate degree in Physical or Life Science or equivalent with 2+ years of related experience; OR
High School diploma with 4+ years of related experience.
Ability to perform complex math functions, compute ratios, rates and percentages.
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
What We Offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.
Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.
Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent . Be willing. Be reliable.
