Manufacturing/Documentation Specialist
Must have:
Quality document ownership process is the most important part - will ask about creation ownership for these type of records.
Need to be strong in the quality record/document ownership piece; deviations, CAPAs change controls – they will be the owners of these areas and need to be well versed in this space, no time to train, if not strong in deviation topics, explaining, executing, articulating, won’t be a fit here. They will talk to them about creating, owning these documents.
M-F first shift role (fully onsite)
Salary target ~$75-85K base, 10% bonus target, will have bonus and long term incentives (stock)
This role supports manufacturing (they aren’t a tech on the line but a background in manufacturing is what they will need here), GMP is an absolute must, needs to have deviation/CAPA experience, procedural updates are the bulk of the role, process improvements and project teams, cross functional work is about 5%. They need to have industry experience but if they don’t have the cell/gene therapy, that isn’t a must.
Covid – vax not required
Fullly onsite
Essential Functions and Responsibilities
- Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
- Lead teams investigating minor, major and critical non conformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
- Own and manage change controls associated with manufacturing areas and equipment.
- Participate in technology transfer, conference calls and sharing of technical information.
- Coordination of front-end document requests with supporting departments.
- Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
- Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Attends the weekly management meeting to discuss timelines and weekly priorities.
- Contribute to projects to ensure timely initiation and completion of work.
- May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
- Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.
- Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Travel
- May require up to 10% travel, based on business need.
Required Education, Skills, and Knowledge
- Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must.
- Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing department representing a variety of personalities and experience levels.
- Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
- Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
- Ability to work successfully in a fast-paced, team-oriented environment.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Excellent presentation skills, both written and verbal.
- Understands and complies with quality standards and requirements as documented.
- Must have strong written and verbal communication and organizational skills.
- Strong computer skills, problem solving and attention to detail.
- Familiarity with data and sample management required (LIMS/MES)
- Able to work independently with minimal supervision.
- This position is currently for regular work week hours (1st shift M-F)
- Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required:
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Able to stand and/or walk 90% (and sit 10%) which may include climbing ladders or steps.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 45 pounds.
Mental:
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
- This position will work in both an office and a manufacturing cleanroom setting.
- When in the lab, must be able to work in cleanroom setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in cleanroom with biohazards, human blood components, and chemicals.
- Potential exposure to noise and equipment hazards and strong odors.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
