Documentation Specialist

BCforward is currently seeking a highly motivated Documentation Specialist for an opportunity in Oceanside, CA 92056!

Position Title: Documentation Specialist

Location: Oceanside, CA 92056

Anticipated Start Date: 02/25/2025

Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.

Expected Duration: 8+ Months of contract with possible extension

Job Type: [FULL TIME (>%3D30 HRS WEEKLY)], [CONTRACT], [Onsite]

Pay Range: $37.00 - $40.00/hr.

Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.).

Requirements:

• GMP facility.
• GMP Documents.

Job Description:

Job Summary:

Responsible for owning and overseeing all Site Operations documents through creation and revision, the Site Operations Documentation Specialist helps to define and adhere to documentation guidelines by managing document change requests, working closely with technical collaborators, redlining documents, and ensuring timely completion of all Site Operations change records. Their knowledge needs to be deep in Site Operations bioprocessing, document revision, the Quality/ GMP change control process, and project management capabilities.

Job Responsibilities:

Own and oversee the Facilities and Engineering document creation and revision process.

Perform Change Owner responsibilities for Site Operations by managing process area and system change records including quality actions, technology transfer changes, shutdown activities, inspection responses, and other Site Operations continuous improvements projects.

Review all Site Operations revision requests and collaborate with technical experts and stakeholders to align on document revision prioritization, necessity, and improvement opportunities.

Establish and implement business processes to optimize Site Operations document revision.

Establish and implement documentation guiding principles that align with site training strategy, tech transfer readiness, and adhere to GMP regulatory requirements.

Lead document revision teams and work streams, as necessary.

Collaborate with Site Operations SMEs and technical assessors for document creation and revision.

Redline documents using technical knowledge and knowledge of SOPs.

Act as Veeva and Eval Subject Matter Experts.

Act as Site Operations Document Subject Matter Expert.

Train others across the organization on document control processes and procedures, as necessary.

Collaborate with Technical Training and Training Program Coordinators in the Site Operations Learning Group to develop training materials and align on training/documentation strategy and guiding principles.

Utilize and maintain metrics and regularly solicit stakeholder and customer feedback to monitor document efficacy and look for continuous improvement opportunities.

Improve right-first time change initiation.

Provide support to Site Operations Learning Group and GMP Services as required.

Education and Experience:

Bachelor's degree in Biological Sciences, Physical Sciences, Engineering is preferred

3 years' experience in a GMP facility.

3 years' experience revising GMP documents.

Knowledge, Skills and Abilities:

Strong technical knowledge of GMP, SOPs, compliance and safety requirements within a biochemical-Site Operations environment

Strong technical knowledge of the biopharmaceutical Site Operations process and equipment.

Expertise in redlining Site Operations documents.

Expertise in Condor and Track wise.

Working knowledge of regulatory requirements.

Strong technical writing ability.

Strong planning and organizational skills and ability to manage multiple priorities at the same time.

Able to quickly and consistently establish rapport and collaborate effectively with clients, team members and partners.

Commitment to achieving results is reached by applying hard work, understanding how to get things done through both formal channels and informal networks.

Ability to establish measurable goals, monitor and assess others performance and provide timely and relevant feedback, both positive and constructive.

Displays exceptional teamwork and collaboration skills.

Strong verbal and written communication skills.

Work Environment:

Work in a standard office environment.

May work in a clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots must be worn. Also, no make-up or jewelry can be worn when working in a clean room environment.

When working in a clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment.

Also, you may work on a schedule that could include a non-rotating 4-day (10-hour shift), one weekend day, evening or night hours, or full-off-shift hours.

May climb upwards 6 flights of stairs a day to maneuver within the Site Operations facility.

Lifting up to 25lbs may be required.

May work with hazardous materials and chemicals.

Benefits:

BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

Keywords:

[GMP facility, and GMP Documents.]

About BCforward:

Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.

BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.

BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.

This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.

Interested candidates please send resume in Word format Please reference job code 235187 when responding to this ad.