Documentation Specialist - 2nd Shift

· Cipla • Fall River, MA

6d • Onsite

About The Position

Invagen Pharmaceuticals is searching for experienced candidates for the position of Documentation Specialist. The Manufacturing Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP’s. In this role the Documentation Specialist adheres to the company’s document and SOP’s procedures while ensuring their accuracy, quality, and integrity. This position reports to the Site Lead/Operation Manager and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen Pharmaceuticals, Inc, Fall River, MA.

Requirements

• Associate degree with 1-3 years knowledge and experience of GMP documentation required.
• Bachelor’s degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university.
• Minimum one (1) year documentation experience and three (3) years related pharmaceutical or biotech industry experience.
• Excellent communication skills, drive, and sense of urgency
• Excellent computer skills, specifically Microsoft Office Suite.
• Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
• Knowledge of pharmaceutical manufacturing and related documents.
• Knowledge and experience writing, revising and creating cGMP records and SOP’s.
• Knowledge of GDP.
• Creation and maintenance of batch record and cGMP documentation templates.
• Closure of any compliance related CAPA’s.
• Hands-on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems.
• Ability to work effectively both independently and as part of a team.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Proficiently speak English as a first or second language
• Ability to understand and analyze complex data sets.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Position requires flexibility to quickly adapt to changing work environment and schedules
• Excellent organizational skills with the ability to focus on details.
• Basic computer skills (Word and Excel) – Intermediate
• Good basic math knowledge and excellent attention to details.
• Must be willing to work in a pharmaceutical manufacturing setting.

Nice To Haves

• Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.
• Preference will be given to candidates with experience in generic pharmaceutical manufacturing.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.
• Knowledge and handling of deviation, CAPA, change control, FMECA, OOS, OOT, training and OOAC.
• Knowledge and handling of SAP system, master control and TrackWise system.
• Knowledge of p reparation of BMR and eBMR.
• Knowledge of p reparation of SOP and eLog books.
• During audit part of team.
• Planning of batches as per production plan.
• Knowledge of audits and compliance .
• Knowledge of statistical packages is a plus.

Responsibilities

• Works with Manufacturing/Packaging to deliver timely batch record review across all shifts.
• Reviews and approval of master batch records.
• Develops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets.
• Generates and reports on metrics on agreed frequency
• Creates training materials for subject matter input.
• Track and manage periodic review of approved procedures.
• Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance.
• Provides data to support management evaluation of performance trends.
• Owns quality records (change control, CAPA’s, deviations) and delivers to established timelines.
• Autonomously leads and manages projects to implement continuous improvement opportunities.
• Lead and/or support root cause investigations related to performance trends and formal deviations.
• Develop, implement and assess solutions for complex problems.
• Anticipates risk and builds contingencies to help mitigate impact.
• Reviews document for accuracy and completeness.
• Defends the validation programs and strategies to customers and regulatory auditors.
• Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols.
• Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.
• Performs other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level