Manufacturing Specialist

BCforward is currently seeking a highly motivated Manufacturing Specialist in Harmans, MD 21077

Job Title: Manufacturing Specialist

Duration: 1 Year

Location: Harmans, MD 21077

Anticipated Start Date: ASAP
(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.)

Job Type: Contract (40 hrs. a week)

Pay Range: $20hr-$21/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.).

Work Schedule: MON-FRI 8AM - 5PM

Job Description:

• The Manufacturing Technical Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates.
• The Manufacturing Technical Specialist will be responsible for, executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.
• The Manufacturing Technical Specialist role is critical to our patients.
• Manufacturing life-saving medicines right the first time with patient safety in mind is our priority.
• Quality, safety and on-time delivery is a must to be successful in this role!

The Role

• Initiates Quality Records and conducts deviation investigations that meeting both Industry and client expectations
• Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
• Develops, executes and oversees CAPAs
• Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
• Supports Tech transfer and process monitoring support as needed
• Works with the team to monitor critical process parameters
• Revision and management of manufacturing documents such as Batch Records and SOPs
• Leads or supports Continuous Improvement projects
• Conducts data gathering, trending, and data presentation as needed to support investigations
• Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.

The Candidate

• Bachelor's degree in a science or engineering field and 4+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
• Previous experience operating equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
• 3+ years of experience in process deviation investigations and remediation
• Ability to perform interviews and familiarity with root cause analysis
• Previous experience authoring and/or revising technical documents
• Ability to support and/or lead system troubleshooting efforts

Key leadership attributes:

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

Position Benefits

• Potential for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization

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.

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 234716 when responding to this ad.