What are the responsibilities and job description for the Manufacturing Doc Specialist II position at Bio-Rad?
A typical day will consist of creating / revising production, QC, dispensing, and packaging procedures. Creating / revising Material Specifications, label templates, and label contents. Creating / routing DIR / ERs for approval, monitoring the status of the DIR / ER. Assist with WI creation / update in Veeva. Filing and archiving batch records when needed etc.
How You’ll Make An Impact :
- Contribute to timely product release to meet the business goals to deliver product to customers on time by completing assigned tasks on time.
- Communicating technical issues and concerns promptly to escalate / establish root cause to move the process forward.
- Identify areas for improvement in documentation processes / procedures and execute projects to implement changes.
- Collaborates with the Quality department to manage and track Change Requests.
- Creates or revises new materials and new material specifications.
- Creates or Revises production procedure / QC procedures.
- Reviews documents for format, accuracy and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts.
- Creates and revises label specifications in Label Content Records (LCRs), templates and processes manufacturing updates through DIR workflow.
- Participates in CR Meetings and NPIs as required to support creating and revising documents and ERP data.
- Maintains the Document Storage Area for all controlled documents.
- Conduct manual create Recipe and BOM setup on SAP.
- Troubleshoot for label printing issues as needed.
- Create department SOPs, Work Instruction, Packaging / dispensing procedures if needed.
- Trains new Documentation Specialists.
- Perform required Product Lifecycle Management (PLM) System changes through document routing approval, Tier 2, and Engineering Records (ER) release as needed.
- Filling / archiving product batch records.
- Evaluate change requests / logging the requests.
- Update / create KMI.
- Education : Bachelor’s degree or equivalent in a related field.
- Work Experience : 0-2 years documentation related experience. 1 years of quality engineering related experience.
- Strong communication MS Office especiallly strong on word and excel.
- Strong customer orientation and focus.
- Familiarity with SAP or similar ERP systems a plus.
- Understanding of ISO 13487, FDA regulations. GMP and GLP.
- Know PLM, Veeva, or EtQ is a plus
- Previous work experience in documentation and quality engineering
- A degree in life science or a related field is preferred or a working knowledge of Biology / chemical related procedures.
- A willingness to learn new processes, embrace new ideas and challenges is extremely desirable.
- The ability to flex and adapt to unexpected changes in flexable schedule is extremely desirable.
- The ability to work amongst a small and diverse team and communicate effectively is highly desired due to this role being very collaborative.
What You Bring :
Total Rewards Package : At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.
Benefits : We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more!
Compensation : The estimated base salary range for this position is $68,640 to $92,900 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.
Who We Are : For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
EEO Statement : Bio-Rad is an Equal Employment Opportunity / Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.
Salary : $68,640 - $92,900
